StrokePhase 4NCT00153062

PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

A Phase 4 study testing Aggrenox, Micardis and Clopidogrel in people with Stroke, run by Boehringer Ingelheim at 667 sites in 36 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive… Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Stroke
What is being tested?: Aggrenox, Micardis and Clopidogrel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20,332 participants
Where: 667 sitesin 36 countries
Study dates: Aug 2003to Apr 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors:
Diabetes mellitus
Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)
Smoker at time of qualifying stroke
Obesity (BMI>30; BMI=weight (kg)/[height (m)]2)
Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke)
End-organ-damage (retinopathy, LVH, or microalbuminuria)
Hyperlipidemia

Who cannot join

hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding ;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of dementia;modified Rankin score greater than 4;qualifying stroke induced by surgical or cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmHg (goal BPs are lower); SBP 120 mmHg or less for hospitalized patients; currently taking an ARB and not able or willing to switch to alternative; required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial; history of thrombocytopenia or neutropenia.

Trial locations and contacts

667 sites in 36 countries.

Country

City, postcode or hospital

667 sites in 36 countries

United States204 sites

9.159.1171 Boehringer Ingelheim Investigational Site
Abington, Pennsylvania
9.159.1159 Boehringer Ingelheim Investigational Site
Akron, Ohio
9.159.1086 Boehringer Ingelheim Investigational Site
Albany, New York
9.159.1170 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
9.159.1210 Boehringer Ingelheim Investigational Site
Allentown, Pennsylvania
9.159.1214 Boehringer Ingelheim Investigational Site
Allentown, Pennsylvania
9.159.1099 Boehringer Ingelheim Investigational Site
Asheville, North Carolina
9.159.1071 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
9.159.1079 Boehringer Ingelheim Investigational Site
Augusta, Georgia
9.159.1024 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
9.159.1055 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
9.159.1139 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
9.159.1106 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
9.159.1057 Boehringer Ingelheim Investigational Site
Bay Pines, Florida
9.159.1040 Boehringer Ingelheim Investigational Site
Berkeley, California
9.159.1101 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
9.159.1215 Boehringer Ingelheim Investigational Site
Bismarck, North Dakota
9.159.1217 Boehringer Ingelheim Investigational Site
Boca Raton, Florida
9.159.1189 Boehringer Ingelheim Investigational Site
Boise, Idaho
9.159.1031 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
9.159.1066 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
9.159.1104 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
9.159.1166 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
9.159.1003 Boehringer Ingelheim Investigational Site
Bountiful, Utah
9.159.1096 Boehringer Ingelheim Investigational Site
Bradenton, Florida
9.159.1006 Boehringer Ingelheim Investigational Site
Bristol, Tennessee
9.159.1017 Boehringer Ingelheim Investigational Site
Brooklyn, New York
9.159.1064 Boehringer Ingelheim Investigational Site
Brooklyn, New York
9.159.1186 Boehringer Ingelheim Investigational Site
Brooklyn, New York
9.159.1219 Boehringer Ingelheim Investigational Site
Brownwood, Texas
9.159.1151 Boehringer Ingelheim Investigational Site
Buffalo, New York
9.159.1204 Boehringer Ingelheim Investigational Site
Camden, New Jersey
9.159.1085 Boehringer Ingelheim Investigational Site
Canton, Ohio
9.159.1180 Boehringer Ingelheim Investigational Site
Carmichael, California
9.159.1027 Boehringer Ingelheim Investigational Site
Cedar Rapids, Iowa
9.159.1046 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina
9.159.1211 Boehringer Ingelheim Investigational Site
Charleston, West Virginia
9.159.1026 University of Illinois
Chicago, Illinois
9.159.1033 Boehringer Ingelheim Investigational Site
Chicago, Illinois
9.159.1060 Boehringer Ingelheim Investigational Site
Chicago, Illinois
9.159.1032 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
9.159.1144 Boehringer Ingelheim Investigational Site
Clearwater, Florida
9.159.1025 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
9.159.1177 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
9.159.1140 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
9.159.1181 Boehringer Ingelheim Investigational Site
Columbus, Georgia
9.159.1008 Boehringer Ingelheim Investigational Site
Columbus, Ohio
9.159.1141 Boehringer Ingelheim Investigational Site
Columbus, Ohio
9.159.1155 Boehringer Ingelheim Investigational Site
Dallas, Texas
9.159.1197 Boehringer Ingelheim Investigational Site
Dallas, Texas
9.159.1038 Boehringer Ingelheim Investigational Site
Danbury, Connecticut
9.159.1138 Boehringer Ingelheim Investigational Site
Decatur, Georgia
9.159.1118 Boehringer Ingelheim Investigational Site
Denver, Colorado
9.159.1119 Boehringer Ingelheim Investigational Site
Des Moines, Iowa
9.159.1187 Boehringer Ingelheim Investigational Site
Des Moines, Iowa
9.159.1019 Boehringer Ingelheim Investigational Site
Detroit, Michigan
9.159.1048 Boehringer Ingelheim Investigational Site
Detroit, Michigan
9.159.1089 Boehringer Ingelheim Investigational Site
Detroit, Michigan
9.159.1088 Boehringer Ingelheim Investigational Site
Duluth, Minnesota
9.159.1158 Boehringer Ingelheim Investigational Site
Duluth, Minnesota
9.159.1094 Boehringer Ingelheim Investigational Site
Durham, North Carolina
9.159.1078 Boehringer Ingelheim Investigational Site
East Lansing, Michigan
9.159.1203 Boehringer Ingelheim Investigational Site
Edison, New Jersey
9.159.1156 Boehringer Ingelheim Investigational Site
Elkhart, Indiana
9.159.1045 Boehringer Ingelheim Investigational Site
Englewood, Colorado
9.159.1200 Boehringer Ingelheim Investigational Site
Erie, Pennsylvania
9.159.1196 Boehringer Ingelheim Investigational Site
Fairfield, Connecticut
9.159.1152 Boehringer Ingelheim Investigational Site
Fargo, North Dakota
9.159.1184 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas
9.159.1007 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
9.159.1005 Boehringer Ingelheim Investigational Site
Fort Smith, Arkansas
9.159.1084 Boehringer Ingelheim Investigational Site
Golden Valley, Minnesota
9.159.1143 Boehringer Ingelheim Investigational Site
Grand Rapids, Michigan
9.159.1146 Boehringer Ingelheim Investigational Site
Great Falls, Montana
9.159.1043 Boehringer Ingelheim Investigational Site
Greensburg, Pennsylvania
9.159.1207 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
9.159.1018 Boehringer Ingelheim Investigational Site
Hartford, Connecticut
9.159.1164 Boehringer Ingelheim Investigational Site
Hershey, Pennsylvania
9.159.1012 Boehringer Ingelheim Investigational Site
High Point, North Carolina
9.159.1020 Boehringer Ingelheim Investigational Site
Houston, Texas
9.159.1023 Boehringer Ingelheim Investigational Site
Houston, Texas
9.159.1082 Boehringer Ingelheim Investigational Site
Houston, Texas
9.159.1160 Boehringer Ingelheim Investigational Site
Houston, Texas
9.159.1173 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
9.159.1059 Boehringer Ingelheim Investigational Site
Iowa City, Iowa
9.159.1114 Boehringer Ingelheim Investigational Site
Irvine, California
9.159.1190 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
9.159.1136 Boehringer Ingelheim Investigational Site
Jonesboro, Arkansas
9.159.1102 Boehringer Ingelheim Investigational Site
Kalamazoo, Michigan
9.159.1090 Boehringer Ingelheim Investigational Site
Kansas City, Kansas
9.159.1128 St. Luke's Hospital MABSI Research
Kansas City, Missouri
9.159.1154 Boehringer Ingelheim Investigational Site
Knoxville, Tennessee
9.159.1202 Boehringer Ingelheim Investigational Site
Laguna Hills, California
9.159.1175 Boehringer Ingelheim Investigational Site
Lancaster, Pennsylvania
9.159.1127 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
9.159.1172 Boehringer Ingelheim Investigational Site
Lees Summit, Missouri
9.159.1129 Central Baptis Hospital
Lexington, Kentucky
9.159.1131 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
9.159.1206 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
9.159.1212 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
9.159.1062 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
9.159.1036 Boehringer Ingelheim Investigational Site
Los Angeles, California
9.159.1052 Boehringer Ingelheim Investigational Site
Los Angeles, California
9.159.1100 Boehringer Ingelheim Investigational Site
Los Angeles, California
9.159.1111 Boehringer Ingelheim Investigational Site
Los Angeles, California
9.159.1165 Boehringer Ingelheim Investigational Site
Los Angeles, California
9.159.1091 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
9.159.1147 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
9.159.1042 Neurology Consultants of Burlington County
Lumberton, New Jersey
9.159.1076 North Shore University Hospital
Manasset, New York
9.159.1194 Boehringer Ingelheim Investigational Site
Marrero, Louisiana
9.159.1030 Boehringer Ingelheim Investigational Site
Marshfield, Wisconsin
9.159.1044 Boehringer Ingelheim Investigational Site
Maywood, Illinois
9.159.1213 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
9.159.1117 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
9.159.1037 Boehringer Ingelheim Investigational Site
Mineola, New York
9.159.1097 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
9.159.1113 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
9.159.1058 Boehringer Ingelheim Investigational Site
Mobile, Alabama
9.159.1087 Boehringer Ingelheim Investigational Site
Montgomery, Alabama
9.159.1035 Boehringer Ingelheim Investigational Site
Morgantown, West Virginia
9.159.1075 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
9.159.1209 Boehringer Ingelheim Investigational Site
New Brunswick, New Jersey
9.159.1220 Boehringer Ingelheim Investigational Site
New Hyde Park, New York
9.159.1083 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
9.159.1001 Boehringer Ingelheim Investigational Site
New York, New York
9.159.1116 Boehringer Ingelheim Investigational Site
New York, New York
9.159.1142 Saint Luke's-Roosevelt Hospital
New York, New York
9.159.1080 Boehringer Ingelheim Investigational Site
Newark, Delaware
9.159.1125 Boehringer Ingelheim Investigational Site
Newark, New Jersey
9.159.1077 Boehringer Ingelheim Investigational Site
Newport News, Virginia
9.159.1081 Boehringer Ingelheim Investigational Site
Northport, Alabama
9.159.1150 Boehringer Ingelheim Investigational Site
Ocala, Florida
9.159.1134 Boehringer Ingelheim Investigational Site
Oceanside, California
9.159.1199 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
9.159.1201 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
9.159.1002 Boehringer Ingelheim Investigational Site
Palo Alto, California
9.159.1054 Boehringer Ingelheim Investigational Site
Palos Heights, Illinois
9.159.1153 Boehringer Ingelheim Investigational Site
Panama City, Florida
9.159.1068 Boehringer Ingelheim Investigational Site
Park Ridge, Illinois
9.159.1178 Boehringer Ingelheim Investigational Site
Peoria, Illinois
9.159.1016 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
9.159.1056 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
9.159.1074 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
9.159.1022 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
9.159.1133 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
9.159.1149 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
9.159.1112 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
9.159.1041 Boehringer Ingelheim Investigational Site
Plantation, Florida
9.159.1072 Boehringer Ingelheim Investigational Site
Port Charlotte, Florida
9.159.1010 Boehringer Ingelheim Investigational Site
Portland, Oregon
9.159.1123 Boehringer Ingelheim Investigational Site
Providence, Rhode Island
9.159.1108 Boehringer Ingelheim Investigational Site
Redding, California
9.159.1188 Boehringer Ingelheim Investigational Site
Reno, Nevada
9.159.1021 Boehringer Ingelheim Investigational Site
Richmond, Virginia
9.159.1095 Boehringer Ingelheim Investigational Site
Ridgewood, New Jersey
9.159.1070 Boehringer Ingelheim Investigational Site
Rome, Georgia
9.159.1013 Boehringer Ingelheim Investigational Site
Sacramento, California
9.159.1198 Boehringer Ingelheim Investigational Site
Sacramento, California
9.159.1011 Boehringer Ingelheim Investigational Site
Saginaw, Michigan
9.159.1061 Boehringer Ingelheim Investigational Site
Salem, Virginia
9.159.1047 Boehringer Ingelheim Investigational Site
San Antonio, Texas
9.159.1029 Boehringer Ingelheim Investigational Site
San Diego, California
9.159.1185 Boehringer Ingelheim Investigational Site
San Francisco, California
9.159.1218 Boehringer Ingelheim Investigational Site
San Jose, California
9.159.1179 Boehringer Ingelheim Investigational Site
Santa Rosa, California
9.159.1063 Boehringer Ingelheim Investigational Site
Sarasota, Florida
9.159.1107 Boehringer Ingelheim Investigational Site
Savannah, Georgia
9.159.1126 Boehringer Ingelheim Investigational Site
Schenectady, New York
9.159.1014 Boehringer Ingelheim Investigational Site
Seattle, Washington
9.159.1195 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
9.159.1092 Boehringer Ingelheim Investigational Site
South Bend, Indiana
9.159.1192 Boehringer Ingelheim Investigational Site
South Weymouth, Massachusetts
9.159.1132 Boehringer Ingelheim Investigational Site
Southfield, Michigan
9.159.1004 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
9.159.1145 Boehringer Ingelheim Investigational Site
Spokane, Washington
9.159.1009 Boehringer Ingelheim Investigational Site
Springfield, Missouri
9.159.1174 Boehringer Ingelheim Investigational Site
St Louis, Missouri
9.159.1182 Boehringer Ingelheim Investigational Site
St Louis, Missouri
9.159.1191 Boehringer Ingelheim Investigational Site
St Louis, Missouri
9.159.1163 Boehringer Ingelheim Investigational Site
Stony Brook, New York
9.159.1162 Boehringer Ingelheim Investigational Site
Sylmar, California
9.159.1208 Boehringer Ingelheim Investigational Site
Tampa, Florida
9.159.1121 Boehringer Ingelheim Investigational Site
The Bronx, New York
9.159.1130 Boehringer Ingelheim Investigational Site
The Bronx, New York
9.159.1053 Boehringer Ingelheim Investigational Site
Toledo, Ohio
9.159.1169 Boehringer Ingelheim Investigational Site
Tonawanda, New York
9.159.1183 Boehringer Ingelheim Investigational Site
Torrance, California
9.159.1137 Boehringer Ingelheim Investigational Site
Tucson, Arizona
9.159.1069 Boehringer Ingelheim Investigational Site
Tyler, Texas
9.159.1148 Boehringer Ingelheim Investigational Site
Upland, Pennsylvania
9.159.1049 Boehringer Ingelheim Investigational Site
Vero Beach, Florida
9.159.1205 Boehringer Ingelheim Investigational Site
Walnut Creek, California
9.159.1120 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
9.159.1216 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
9.159.1135 Boehringer Ingelheim Investigational Site
Waterloo, Iowa
9.159.1098 Community Healthcare Clinic Westhill Medical Specialists
Wausau, Wisconsin
9.159.1176 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
9.159.1065 Boehringer Ingelheim Investigational Site
White Plains, New York
9.159.1115
Wilmington, North Carolina
9.159.1051 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
9.159.1110 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
9.159.1039 Boehringer Ingelheim Investigational Site
Worchester, Massachusetts
9.159.1122 Boehringer Ingelheim Investigational Site
Youngstown, Ohio

Other trials in United States

Canada42 sites

9.159.1393 Boehringer Ingelheim Investigational Site
Barrie, Ontario
9.159.1397 Foothills Medical Centre
Calgary, Alberta
9.159.1392 Boehringer Ingelheim Investigational Site
Corner Brook, Newfoundland and Labrador
9.159.1382 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
9.159.1359 Boehringer Ingelheim Investigational Site
Greenfield Park, Quebec
9.159.1395 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
9.159.1370 Boehringer Ingelheim Investigational Site
Kamloops, British Columbia
9.159.1360 Boehringer Ingelheim Investigational Site
Kingston, Ontario
9.159.1390 Boehringer Ingelheim Investigational Site
Lethbridge, Alberta
9.159.1367 Boehringer Ingelheim Investigational Site
London, Ontario
9.159.1384 Boehringer Ingelheim Investigational Site
London, Ontario
9.159.1380 Boehringer Ingelheim Investigational Site
Mississauga, Ontario
9.159.1361 Boehringer Ingelheim Investigational Site
Montreal, Quebec
9.159.1362 Boehringer Ingelheim Investigational Site
Montreal, Quebec
9.159.1371 Boehringer Ingelheim Investigational Site
Montreal, Quebec
9.159.1374 Boehringer Ingelheim Investigational Site
Montreal, Quebec
9.159.1388 Boehringer Ingelheim Investigational Site
Montreal, Quebec
9.159.1368 Boehringer Ingelheim Investigational Site
New Westminster, British Columbia
9.159.1378 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
9.159.1381 Ottawa Hospital General Campus
Ottawa, Ontario
9.159.1376 Boehringer Ingelheim Investigational Site
Penticton, British Columbia
9.159.1372 Boehringer Ingelheim Investigational Site
Québec, Quebec
9.159.1389 Boehringer Ingelheim Investigational Site
Regina, Saskatchewan
9.159.1366 Boehringer Ingelheim Investigational Site
Richmond Hill, Ontario
9.159.1358 Boehringer Ingelheim Investigational Site
Saguenay, Quebec
9.159.1356 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick
9.159.1364 Boehringer Ingelheim Investigational Site
Saint-Jérôme, Quebec
9.159.1396 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
9.159.1365 Boehringer Ingelheim Investigational Site
Scarborough Village, Ontario
9.159.1375 Boehringer Ingelheim Investigational Site
Scarborough Village, Ontario
9.159.1385 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
9.159.1373 Boehringer Ingelheim Investigational Site
Sydney, Nova Scotia
9.159.1391 Boehringer Ingelheim Investigational Site
Tecumseh, Ontario
9.159.1369 Boehringer Ingelheim Investigational Site
Thunder Bay, Ontario
9.159.1357 Boehringer Ingelheim Investigational Site
Toronto, Ontario
9.159.1379 Boehringer Ingelheim Investigational Site
Toronto, Ontario
9.159.1383 Boehringer Ingelheim Investigational Site
Toronto, Ontario
9.159.1387 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
9.159.1377 Boehringer Ingelheim Investigational Site
Victoria, British Columbia
9.159.1363 Boehringer Ingelheim Investigational Site
Windsor, Ontario
9.159.1355 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba
9.159.1394 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

Russia41 sites

9.159.2102 Boehringer Ingelheim Investigational Site
Kazan'
9.159.2117 Boehringer Ingelheim Investigational Site
Kemerovo
9.159.2107 Boehringer Ingelheim Investigational Site
Kirov
9.159.2116 Boehringer Ingelheim Investigational Site
Krasnoyarsk
9.159.2079 Boehringer Ingelheim Investigational Site
Moscow
9.159.2080 Boehringer Ingelheim Investigational Site
Moscow
9.159.2081 Boehringer Ingelheim Investigational Site
Moscow
9.159.2082 Boehringer Ingelheim Investigational Site
Moscow
9.159.2083 Boehringer Ingelheim Investigational Site
Moscow
9.159.2084 Boehringer Ingelheim Investigational Site
Moscow
9.159.2085 Boehringer Ingelheim Investigational Site
Moscow
9.159.2087 Boehringer Ingelheim Investigational Site
Moscow
9.159.2088 Boehringer Ingelheim Investigational Site
Moscow
9.159.2089 Boehringer Ingelheim Investigational Site
Moscow
9.159.2090 Boehringer Ingelheim Investigational Site
Moscow
9.159.2091 Boehringer Ingelheim Investigational Site
Moscow
9.159.2092 Boehringer Ingelheim Investigational Site
Moscow
9.159.2093 Boehringer Ingelheim Investigational Site
Moscow
9.159.2095 Boehringer Ingelheim Investigational Site
Moscow
9.159.2098 Boehringer Ingelheim Investigational Site
Moscow
9.159.2101 Boehringer Ingelheim Investigational Site
Moscow
9.159.2105 Boehringer Ingelheim Investigational Site
Nizhnyi Novgorod
9.159.2115 Boehringer Ingelheim Investigational Site
Novosibirsk
9.159.2119 Boehringer Ingelheim Investigational Site
Omsk
9.159.2111 Boehringer Ingelheim Investigational Site
Oryol
9.159.2106 Boehringer Ingelheim Investigational Site
Rostov-on-Don
9.159.2094 Boehringer Ingelheim Investigational Site
Saint Petersburg
9.159.2097 Boehringer Ingelheim Investigational Site
Saint Petersburg
9.159.2099 Boehringer Ingelheim Investigational Site
Saint Petersburg
9.159.2100 Boehringer Ingelheim Investigational Site
Saint Petersburg
9.159.2108 Boehringer Ingelheim Investigational Site
Samara
9.159.2109 Boehringer Ingelheim Investigational Site
Saratov
9.159.2110 Boehringer Ingelheim Investigational Site
Saratov
9.159.2118 Boehringer Ingelheim Investigational Site
Seversk
9.159.2086 Boehringer Ingelheim Investigational Site
Smolensk
9.159.2120 Boehringer Ingelheim Investigational Site
Ufa
9.159.2112 Boehringer Ingelheim Investigational Site
Volgograd
9.159.2113 Boehringer Ingelheim Investigational Site
Volgograd
9.159.2104 Boehringer Ingelheim Investigational Site
Voronezh
9.159.2103 Boehringer Ingelheim Investigational Site
Yaroslavl
9.159.2114 Boehringer Ingelheim Investigational Site
Yekaterinburg

Other trials in Russia

Japan40 sites

9.159.2964 Boehringer Ingelheim Investigational Site
Adachi-ku, Tokyo
9.159.2958 Boehringer Ingelheim Investigational Site
Akashi, Hyogo
9.159.2970 Boehringer Ingelheim Investigational Site
Akashi, Hyogo
9.159.2965 Boehringer Ingelheim Investigational Site
Ako, Hyogo
9.159.2968 Boehringer Ingelheim Investigational Site
Aoba-ku, Yokohama, Kanagawa
9.159.2951 Boehringer Ingelheim Investigational Site
Azumino, Nagano
9.159.2959 Boehringer Ingelheim Investigational Site
Chitose, Hokkaido
9.159.2944 Boehringer Ingelheim Investigational Site
Chuo-ku, Kobe, Hyogo
9.159.2947 Boehringer Ingelheim Investigational Site
Chuo-Ku, Sapporo, Hokkaido
9.159.2954 Boehringer Ingelheim Investigational Site
Fushimi-ku, Kyoto, Kyoto
9.159.2942 Boehringer Ingelheim Investigational Site
Habikino, Osaka
9.159.2948 Boehringer Ingelheim Investigational Site
Higashi-ku, Sapporo, Hokkaido
9.159.2957 Boehringer Ingelheim Investigational Site
Higashi-osaka, Osaka
9.159.2940 Boehringer Ingelheim Investigational Site
Higashinari-ku, Osaka, Osaka
9.159.2973 Boehringer Ingelheim Investigational Site
Higashiyodogawa-ku, Osaka, Osaka
9.159.2949 Boehringer Ingelheim Investigational Site
Hitachinaka, Ibaraki
9.159.2953 Boehringer Ingelheim Investigational Site
Iida, Nagano
9.159.2943 Boehringer Ingelheim Investigational Site
Izumisano, Osaka
9.159.2963 Boehringer Ingelheim Investigational Site
Jyonan-ku, Fukuoka, Fukuoka
9.159.2933 Boehringer Ingelheim Investigational Site
Kasama, Ibaraki
9.159.2955 Boehringer Ingelheim Investigational Site
Kasuga, Fukuoka
9.159.2938 Boehringer Ingelheim Investigational Site
Kita-ku, Osaka, Osaka
9.159.2967 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
9.159.2969 Boehringer Ingelheim Investigational Site
Kushiro
9.159.2952 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
9.159.2961 Boehringer Ingelheim Investigational Site
Midori-ku, Yokohama, Kanagawa
9.159.2934 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki
9.159.2971 Boehringer Ingelheim Investigational Site
Musashino, Tokyo
9.159.2962 Boehringer Ingelheim Investigational Site
Nakagawa-ku, Nagoya, Aichi
9.159.2939 Boehringer Ingelheim Investigational Site
Nishi-yodogawa-ku, Osaka, Osaka
9.159.2956 Boehringer Ingelheim Investigational Site
Ohnojo, Fukuoka
9.159.2941 Boehringer Ingelheim Investigational Site
Sakai-ku, Sakai, Osaka
9.159.2945 Boehringer Ingelheim Investigational Site
Sawara-ku, Fukuoka, Fukuoka
9.159.2937 Boehringer Ingelheim Investigational Site
Shimogyo-ku, Kyoto, Kyoto
9.159.2966 Boehringer Ingelheim Investigational Site
Shiroishi, Miyagi
9.159.2936 Boehringer Ingelheim Investigational Site
Suwa, Nagano
9.159.2946 Boehringer Ingelheim Investigational Site
Takikawa, Hokkaido
9.159.2935 Boehringer Ingelheim Investigational Site
Tatebayashi, Gunma
9.159.2950 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki
9.159.2972 Boehringer Ingelheim Investigational Site
Yao, Osaka

Other trials in Japan

China38 sites

9.159.2490 Boehringer Ingelheim Investigational Site
Beijing
9.159.2491 Boehringer Ingelheim Investigational Site
Beijing
9.159.2492 Boehringer Ingelheim Investigational Site
Beijing
9.159.2493 Boehringer Ingelheim Investigational Site
Beijing
9.159.2494 Boehringer Ingelheim Investigational Site
Beijing
9.159.2495 Boehringer Ingelheim Investigational Site
Beijing
9.159.2496 Boehringer Ingelheim Investigational Site
Beijing
9.159.2503 Boehringer Ingelheim Investigational Site
Changchun, Jilin Province
9.159.2500 Boehringer Ingelheim Investigational Site
Changsha, Hunan Province
9.159.2513 Boehringer Ingelheim Investigational Site
Chengdu, Sichuan Province
9.159.2512 Boehringer Ingelheim Investigational Site
Chongqing
9.159.2509 Boehringer Ingelheim Investigational Site
Guangzhou
9.159.2518 Boehringer Ingelheim Investigational Site
Guangzhou
9.159.2521 Boehringer Ingelheim Investigational Site
Guangzhou
9.159.2507 Boehringer Ingelheim Investigational Site
Guangzhou, Guangdong Province
9.159.2510 Boehringer Ingelheim Investigational Site
Guangzhou, Guangdong Province
9.159.2502 Boehringer Ingelheim Investigational Site
Hangzhou, Zhejiang Province
9.159.2504 Boehringer Ingelheim Investigational Site
Harbin, Heilongjiang Province
9.159.2505 Boehringer Ingelheim Investigational Site
Jinan, Shandong Province
9.159.2506 Boehringer Ingelheim Investigational Site
Jinan, Shangdong Province
9.159.2517 Boehringer Ingelheim Investigational Site
Nanjing, Jiangsu Province
9.159.2519 Boehringer Ingelheim Investigational Site
Nanjing, Jiangsu Province
9.159.2520 Boehringer Ingelheim Investigational Site
Nanjing, Jiangsu Province
9.159.2483 Boehringer Ingelheim Investigational Site
Shanghai
9.159.2484 Boehringer Ingelheim Investigational Site
Shanghai
9.159.2485 Boehringer Ingelheim Investigational Site
Shanghai
9.159.2486 Boehringer Ingelheim Investigational Site
Shanghai
9.159.2487 Boehringer Ingelheim Investigational Site
Shanghai
9.159.2488 Boehringer Ingelheim Investigational Site
Shanghai
9.159.2489 Boehringer Ingelheim Investigational Site
Shanghai
9.159.2516 Boehringer Ingelheim Investigational Site
Suzhou, Jiangsu Province
9.159.2497 Boehringer Ingelheim Investigational Site
Tianjin
9.159.2501 Boehringer Ingelheim Investigational Site
Wenzhou, Zhejiang Province
9.159.2498 Boehringer Ingelheim Investigational Site
Wuhan, Hubei Province
9.159.2499 Boehringer Ingelheim Investigational Site
Wuhan, Hubei Province
9.159.2511 Boehringer Ingelheim Investigational Site
Xi'an
9.159.2514 Boehringer Ingelheim Investigational Site
Xian, Shanxi
9.159.2515 Boehringer Ingelheim Investigational Site
Xian, Shanxi Province

Other trials in China

Germany33 sites

9.159.1713 Boehringer Ingelheim Investigational Site
Bad Neustadt/Saale
9.159.1736 Boehringer Ingelheim Investigational Site
Berlin
9.159.1732 Boehringer Ingelheim Investigational Site
Braunschweig
9.159.1726 Boehringer Ingelheim Investigational Site
Cloppenburg
9.159.1737 Boehringer Ingelheim Investigational Site
Cologne
9.159.1723 Boehringer Ingelheim Investigational Site
Dresden
9.159.1728 Boehringer Ingelheim Investigational Site
Düsseldorf
9.159.1707 Boehringer Ingelheim Investigational Site
Essen
9.159.1738 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
9.159.1720 Boehringer Ingelheim Investigational Site
Giessen
9.159.1722 Boehringer Ingelheim Investigational Site
Hamburg
9.159.1739 Boehringer Ingelheim Investigational Site
Hamburg
9.159.1724 Boehringer Ingelheim Investigational Site
Heidelberg
9.159.1734 Boehringer Ingelheim Investigational Site
Jena
9.159.1730 Boehringer Ingelheim Investigational Site
Kaiserslautern
9.159.1717 Boehringer Ingelheim Investigational Site
Leipzig
9.159.1735 Boehringer Ingelheim Investigational Site
Ludwigshafen am Rhein
9.159.1712 Boehringer Ingelheim Investigational Site
Magdeburg
9.159.1710 Boehringer Ingelheim Investigational Site
Mainz
9.159.1709 Boehringer Ingelheim Investigational Site
Minden
9.159.1716 Boehringer Ingelheim Investigational Site
Mönchengladbach
9.159.1718 Boehringer Ingelheim Investigational Site
München
9.159.1725 Boehringer Ingelheim Investigational Site
München
9.159.1729 Boehringer Ingelheim Investigational Site
München
9.159.1727 Boehringer Ingelheim Investigational Site
Münster
9.159.1711 Boehringer Ingelheim Investigational Site
Nuremberg
9.159.1719 Boehringer Ingelheim Investigational Site
Regensburg
9.159.1731 Boehringer Ingelheim Investigational Site
Remscheid
9.159.1708 Boehringer Ingelheim Investigational Site
Rostock
9.159.1715 Boehringer Ingelheim Investigational Site
Saarbrücken
9.159.1714 Boehringer Ingelheim Investigational Site
Siegen
9.159.1733 Boehringer Ingelheim Investigational Site
Stuttgart
9.159.1721 Boehringer Ingelheim Investigational Site
Weimar

Other trials in Germany

India30 sites

9.159.2605 Boehringer Ingelheim Investigational Site
Annāmalainagar
9.159.2603 Boehringer Ingelheim Investigational Site
Bangalore
9.159.2620 Boehringer Ingelheim Investigational Site
Bangalore
9.159.2616 Boehringer Ingelheim Investigational Site
Bikaner
9.159.2618 Boehringer Ingelheim Investigational Site
Calicut
9.159.2604 Boehringer Ingelheim Investigational Site
Chennai
9.159.2619 Boehringer Ingelheim Investigational Site
Chennai
9.159.2625 Boehringer Ingelheim Investigational Site
Chennai
9.159.2607 Boehringer Ingelheim Investigational Site
Hyderabad
9.159.2624 Boehringer Ingelheim Investigational Site
Hyderabad
9.159.2630 Boehringer Ingelheim Investigational Site
Hyderabad
9.159.2632 Boehringer Ingelheim Investigational Site
Hyderabad
9.159.2610 Boehringer Ingelheim Investigational Site
Indore
9.159.2615 Boehringer Ingelheim Investigational Site
Jaipur
9.159.2617 Boehringer Ingelheim Investigational Site
Jaipur
9.159.2612 Boehringer Ingelheim Investigational Site
Jodhpur
9.159.2606 Boehringer Ingelheim Investigational Site
Kochi
9.159.2621 Boehringer Ingelheim Investigational Site
Kottayam
9.159.2613 Boehringer Ingelheim Investigational Site
Lucknow
9.159.2614 Boehringer Ingelheim Investigational Site
Ludhiana
9.159.2611 Boehringer Ingelheim Investigational Site
Mumbai
9.159.2628 Boehringer Ingelheim Investigational Site
New Delhi
9.159.2629 Boehringer Ingelheim Investigational Site
New Delhi
9.159.2623 Boehringer Ingelheim Investigational Site
Patiāla
9.159.2609 Boehringer Ingelheim Investigational Site
Pune
9.159.2622 Boehringer Ingelheim Investigational Site
Pune
9.159.2627 Boehringer Ingelheim Investigational Site
Secunderabad
9.159.2626 Boehringer Ingelheim Investigational Site
Trichy
9.159.2631 Boehringer Ingelheim Investigational Site
Visakhapatnam
9.159.2608 Boehringer Ingelheim Investigational Site
Wardha

Other trials in India

United Kingdom26 sites

9.159.2304 Boehringer Ingelheim Investigational Site
Belfast
9.159.2297 Boehringer Ingelheim Investigational Site
Birmingham
9.159.2299 Boehringer Ingelheim Investigational Site
Bournemouth
9.159.2301 Boehringer Ingelheim Investigational Site
Bristol
9.159.2298 Boehringer Ingelheim Investigational Site
Dundee
9.159.2307 Boehringer Ingelheim Investigational Site
Exeter
9.159.2296 Boehringer Ingelheim Investigational Site
Glasgow
9.159.2300 Boehringer Ingelheim Investigational Site
Glasgow
9.159.2287 Boehringer Ingelheim Investigational Site
Harrow
9.159.2303 Boehringer Ingelheim Investigational Site
Henshingham, Whitehaven
9.159.2308 Boehringer Ingelheim Investigational Site
Leicester
9.159.2295 Boehringer Ingelheim Investigational Site
Liverpool
9.159.2286 Boehringer Ingelheim Investigational Site
London
9.159.2293 Boehringer Ingelheim Investigational Site
London
9.159.2294 Boehringer Ingelheim Investigational Site
London
9.159.2305 Boehringer Ingelheim Investigational Site
Mansfield
9.159.2290 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne
9.159.2288 Boehringer Ingelheim Investigational Site
North Shields
9.159.2285 Boehringer Ingelheim Investigational Site
Northampton
9.159.2284 Boehringer Ingelheim Investigational Site
Nottingham
9.159.2283 Boehringer Ingelheim Investigational Site
Poole
9.159.2302 Boehringer Ingelheim Investigational Site
Rotherham
9.159.2292 Boehringer Ingelheim Investigational Site
Sheffield
9.159.2289 Boehringer Ingelheim Investigational Site
Southampton
9.159.2306 Boehringer Ingelheim Investigational Site
Stoke-on-Trent
9.159.2291 Boehringer Ingelheim Investigational Site
Sunderland

Other trials in United Kingdom

Italy22 sites

9.159.1875 Università degli Studi di Ancona
Ancona
9.159.1882 Ospedale Brotzu
Cagliari
9.159.1883 Azienda Ospedaliera S. Anna
Como
9.159.1871 Azienda Ospedaliera "Careggi"
Florence
9.159.1869 Università degli Studi di Genova
Genova
9.159.1870 ASL No. 5 di Jesi
Jesi (ancona)
9.159.1865 Ospedale Regionale "S. Salvatore"
L’Aquila
9.159.1866 Ospedale S. Raffaele
Milan
9.159.1873 Istituto Scientifico "S. Luca"
Milan
9.159.1884 Ospedale S. Carlo Borromeo"
Milan
9.159.1868 Ospedale "S. Maria di Loreto Mare"
Naples
9.159.1876 Azienda Ospedaliera di Padova -Policlinico Universitario
Padova
9.159.1874 Ospedale Civico - ARNAS
Palermo
9.159.1872 Neuromed IRCCS
Pozzilli (IS)
9.159.1879 Policlinico S. Andrea
Roma
9.159.1881 Università "La Sapienza"
Roma
9.159.1877 Azienda Ospedaliera Umberto I
Syracuse
9.159.1878 Azienda Ospedaliera "Santo Maria"
Terni
9.159.1864 Azienda Ospedaliera "S. Giovanni Battista"
Torino
9.159.1863 Ospedale di Cattinara
Trieste
9.159.1867 Presidio Ospedaliero G.Jazzolino
Vibo Valentia
9.159.1880 Ospedale Civile
Vicenza

Other trials in Italy

Netherlands22 sites

9.159.1960 Jeroen Bosch Ziekenhuis
's-Hertogenbosch
9.159.1945 Medisch Centrum Alkmaar
Alkmaar
9.159.1963 Polikliniek Neurologie
Assen
9.159.1949 Ziekenhuis Gooi-Noord
Blaricum
9.159.1962 Locatie Molengracht
Breda
9.159.1959 Catharina Ziekenhuis
Eindhoven
9.159.1946 Scheper Ziekenhuis
Emmen
9.159.1958 Medisch Spectrum Twente
Enschede
9.159.1943 Umcg
Groningen
9.159.1961 Lokatie Van Swieten
Groningen
9.159.1953 Atrium Medisch Centrum
Heerlen
9.159.1955 Elkerliek Ziekenhuis
Helmond
9.159.1951 Ziekenhuisgroep Twente
Hengelo
9.159.1948 Medisch Centrum Leeuwarden
Leeuwarden
9.159.1952 Rijnland Ziekenhuis
Leiderdorp
9.159.1947 Sint Antonius Ziekenhuis
Nieuwegein
9.159.1964 Canisius-Wilhelmina ziekenhuis
Nijmegen
9.159.1950 HagaZiekenhuis
The Hague
9.159.1956 TweeSteden Ziekenhuis Tilburg
Tilburg
9.159.1957 Sint Elisabeth Ziekenhuis
Tilburg
9.159.1944 Máxima Medisch Centrum
Veldhoven
9.159.1954 St. Jans Gasthuis
Weert

Other trials in Netherlands

Sweden19 sites

9.159.2223 Boehringer Ingelheim Investigational Site
Borås
9.159.2209 Boehringer Ingelheim Investigational Site
Eskilstuna
9.159.2204 Boehringer Ingelheim Investigational Site
Gothenburg
9.159.2205 Boehringer Ingelheim Investigational Site
Gothenburg
9.159.2728 Neurology Unit
Holon
9.159.2210 Boehringer Ingelheim Investigational Site
Jönköping
9.159.2206 Boehringer Ingelheim Investigational Site
Lund
9.159.2211 Boehringer Ingelheim Investigational Site
Mora
9.159.2208 Boehringer Ingelheim Investigational Site
Örebro
9.159.2216 Boehringer Ingelheim Investigational Site
Skellefteå
9.159.2215 Boehringer Ingelheim Investigational Site
Skövde
9.159.2203 Boehringer Ingelheim Investigational Site
Stockholm
9.159.2212 Boehringer Ingelheim Investigational Site
Stockholm
9.159.2213 Boehringer Ingelheim Investigational Site
Stockholm
9.159.2222 Boehringer Ingelheim Investigational Site
Stockholm
9.159.2225 Boehringer Ingelheim Investigational Site
Stockholm
9.159.2207 Boehringer Ingelheim Investigational Site
Umeå
9.159.2214 Boehringer Ingelheim Investigational Site
Värnamo
9.159.2224 Boehringer Ingelheim Investigational Site
Västervik

Other trials in Sweden

Belgium14 sites

9.159.1553 Boehringer Ingelheim Investigational Site
Aalst
9.159.1543 Boehringer Ingelheim Investigational Site
Anderlecht
9.159.1552 Boehringer Ingelheim Investigational Site
Antwerp
9.159.1546 Boehringer Ingelheim Investigational Site
Bonheiden
9.159.1547 Boehringer Ingelheim Investigational Site
Bruges
9.159.1550 Boehringer Ingelheim Investigational Site
Brussels
9.159.1549 Boehringer Ingelheim Investigational Site
Hasselt
9.159.1555 Boehringer Ingelheim Investigational Site
Kortrijk
9.159.1554 Boehringer Ingelheim Investigational Site
La Louvière
9.159.1544 Boehringer Ingelheim Investigational Site
Leuven
9.159.1548 Boehringer Ingelheim Investigational Site
Montegnée
9.159.1556 Boehringer Ingelheim Investigational Site
Ottignies
9.159.1545 Boehringer Ingelheim Investigational Site
Wilrijk
9.159.1551 Boehringer Ingelheim Investigational Site
Yvoir

Other trials in Belgium

Taiwan12 sites

9.159.2250 Boehringer Ingelheim Investigational Site
Kaohsiung City
9.159.2253 Boehringer Ingelheim Investigational Site
Kaohsiung City
9.159.2248 Boehringer Ingelheim Investigational Site
Taichung
9.159.2249 Boehringer Ingelheim Investigational Site
Taichung
9.159.2251 Boehringer Ingelheim Investigational Site
Tainan
9.159.2244 Boehringer Ingelheim Investigational Site
Taipei
9.159.2245 Boehringer Ingelheim Investigational Site
Taipei
9.159.2246 Boehringer Ingelheim Investigational Site
Taipei
9.159.2247 Boehringer Ingelheim Investigational Site
Taipei
9.159.2252 Boehringer Ingelheim Investigational Site
Taipei
9.159.2254 Boehringer Ingelheim Investigational Site
Taipei
9.159.2243 Boehringer Ingelheim Investigational Site
Taoyuan

Other trials in Taiwan

Ukraine12 sites

9.159.2387 Boehringer Ingelheim Investigational Site
Dnipro
9.159.2384 Boehringer Ingelheim Investigational Site
Kharkiv
9.159.2385 Boehringer Ingelheim Investigational Site
Kharkiv
9.159.2386 Boehringer Ingelheim Investigational Site
Kharkiv
9.159.2392 Boehringer Ingelheim Investigational Site
Kharkiv
9.159.2379 Boehringer Ingelheim Investigational Site
Kyiv
9.159.2380 Boehringer Ingelheim Investigational Site
Kyiv
9.159.2382 Boehringer Ingelheim Investigational Site
Kyiv
9.159.2389 Boehringer Ingelheim Investigational Site
Odesa
9.159.2390 Boehringer Ingelheim Investigational Site
Odesa
9.159.2391 Boehringer Ingelheim Investigational Site
Vinnytzya
9.159.2388 Boehringer Ingelheim Investigational Site
Zaporizhzhya

Other trials in Ukraine

Australia10 sites

9.159.2451 Boehringer Ingelheim Investigational Site
Bedford Park, South Australia
9.159.2443 Boehringer Ingelheim Investigational Site
Box Hill, Victoria
9.159.2444 Boehringer Ingelheim Investigational Site
Gosford, New South Wales
9.159.2450 Boehringer Ingelheim Investigational Site
Herston, Queensland
9.159.2447 Boehringer Ingelheim Investigational Site
Melbourne, Victoria
9.159.2449 Boehringer Ingelheim Investigational Site
New Lambton, New South Wales
9.159.2445 Boehringer Ingelheim Investigational Site
Parkville, Victoria
9.159.2452 Boehringer Ingelheim Investigational Site
Southport, Queensland
9.159.2446 Boehringer Ingelheim Investigational Site
West Heidelberg, Victoria
9.159.2448 Boehringer Ingelheim Investigational Site
Westmead, New South Wales

Other trials in Australia

Denmark10 sites

9.159.1636 Boehringer Ingelheim Investigational Site
Aarhuc C
9.159.1635 Boehringer Ingelheim Investigational Site
Aarhus C
9.159.1639 Boehringer Ingelheim Investigational Site
Esbjerg
9.159.1634 Boehringer Ingelheim Investigational Site
Frederiksberg
9.159.1637 Boehringer Ingelheim Investigational Site
Glostrup Municipality
9.159.1640 Boehringer Ingelheim Investigational Site
Hellerup
9.159.1638 Boehringer Ingelheim Investigational Site
Hvidovre
9.159.1633 Boehringer Ingelheim Investigational Site
København NV
9.159.1631 Boehringer Ingelheim Investigational Site
København Ø
9.159.1632 Boehringer Ingelheim Investigational Site
Odense

Other trials in Denmark

Israel8 sites

9.159.2729 Barzilai Medical Center
Ashkelon
9.159.2721 Neurology Unit
Haifa
9.159.2724 Rambam Medical Center, Tel-Aviv Medical
Haifa
9.159.2723 Boehringer Ingelheim Investigational Site
Israel
9.159.2727 Western Galilee Hospital
Nahariya
9.159.2722 Neurology Unit
Petah Tikva
9.159.2725 Tel Aviv Medical Center
Tel Aviv
9.159.2726 Sheba Medical Center
Tel Litwinsky

Other trials in Israel

Argentina7 sites

9.159.1331 Boehringer Ingelheim Investigational Site
Capital Federal
9.159.1333 Boehringer Ingelheim Investigational Site
Capital Federal
9.159.1334 Boehringer Ingelheim Investigational Site
Capital Federal
9.159.1335 Boehringer Ingelheim Investigational Site
Capital Federal
9.159.1336 Boehringer Ingelheim Investigational Site
Capital Federal
9.159.1332 Boehringer Ingelheim Investigational Site
Rosario, Santa Fe
9.159.1342 Boehringer Ingelheim Investigational Site
Santa Fe

Other trials in Argentina

Austria7 sites

9.159.1515 Boehringer Ingelheim Investigational Site
Graz
9.159.1519 Boehringer Ingelheim Investigational Site
Graz
9.159.1517 Boehringer Ingelheim Investigational Site
Innsbruck
9.159.1516 Boehringer Ingelheim Investigational Site
Linz
9.159.1518 Boehringer Ingelheim Investigational Site
Ma.Gugging/Klosterneuburg
9.159.1520 Boehringer Ingelheim Investigational Site
Sankt Pölten
9.159.1521 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

France7 sites

9.159.1680 Boehringer Ingelheim Investigational Site
Lille
9.159.1683 Boehringer Ingelheim Investigational Site
Limoges
9.159.1681 Boehringer Ingelheim Investigational Site
Marseille
9.159.1679 Boehringer Ingelheim Investigational Site
Nancy
9.159.1685 Boehringer Ingelheim Investigational Site
Paris
9.159.1682 Boehringer Ingelheim Investigational Site
Poitiers
9.159.1684 Boehringer Ingelheim Investigational Site
Tours

Other trials in France

South Africa7 sites

9.159.2060 Boehringer Ingelheim Investigational Site
Bloemfontein
9.159.2056 Boehringer Ingelheim Investigational Site
Cape Town
9.159.2057 Boehringer Ingelheim Investigational Site
Durban
9.159.2055 Boehringer Ingelheim Investigational Site
Johannesburg
9.159.2061 Boehringer Ingelheim Investigational Site
Johannesburg
9.159.2058 Boehringer Ingelheim Investigational Site
Pretoria
9.159.2059 Boehringer Ingelheim Investigational Site
Sunninghill

Other trials in South Africa

South Korea7 sites

9.159.1593 Boehringer Ingelheim Investigational Site
Gwangju
9.159.1595 Boehringer Ingelheim Investigational Site
Incheon
9.159.1592 Boehringer Ingelheim Investigational Site
Kyunggi-do
9.159.1591 Boehringer Ingelheim Investigational Site
Seoul
9.159.1594 Boehringer Ingelheim Investigational Site
Seoul
9.159.1597 Boehringer Ingelheim Investigational Site
Seoul
9.159.1596 Boehringer Ingelheim Investigational Site
Suwon

Other trials in South Korea

Turkey (Türkiye)7 sites

9.159.2830 Boehringer Ingelheim Investigational Site
Ankara
9.159.2829 Boehringer Ingelheim Investigational Site
Antalya
9.159.2831 Boehringer Ingelheim Investigational Site
Bursa
9.159.2827 Boehringer Ingelheim Investigational Site
Eskişehir
9.159.2825 Boehringer Ingelheim Investigational Site
Istanbul
9.159.2826 Boehringer Ingelheim Investigational Site
Istanbul
9.159.2828 Dkuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D.
Izmir

Other trials in Turkey (Türkiye)

Greece6 sites

9.159.1826 Boehringer Ingelheim Investigational Site
Alexandroupoli
9.159.1819 Boehringer Ingelheim Investigational Site
Athens
9.159.1820 Boehringer Ingelheim Investigational Site
Athens
9.159.1821 Boehringer Ingelheim Investigational Site
Athens
9.159.1825 Boehringer Ingelheim Investigational Site
Ioannina
9.159.1824 Boehringer Ingelheim Investigational Site
Pátrai

Other trials in Greece

Spain6 sites

9.159.2179 Boehringer Ingelheim Investigational Site
Alicante
9.159.2177 Boehringer Ingelheim Investigational Site
Barcelona
9.159.2178 Boehringer Ingelheim Investigational Site
Hospitalet de Llobregat (Barcelona)
9.159.2175 Boehringer Ingelheim Investigational Site
Madrid
9.159.2176 Boehringer Ingelheim Investigational Site
Madrid
9.159.2180 Boehringer Ingelheim Investigational Site
Pamplona

Other trials in Spain

Finland5 sites

9.159.1655 Boehringer Ingelheim Investigational Site
Helsinki
9.159.1658 Boehringer Ingelheim Investigational Site
Kuopio
9.159.1659 Boehringer Ingelheim Investigational Site
Lappeenranta
9.159.1656 Boehringer Ingelheim Investigational Site
Oulu
9.159.1657 Boehringer Ingelheim Investigational Site
Seinäjoki

Other trials in Finland

Thailand5 sites

9.159.2797 Boehringer Ingelheim Investigational Site
Bangkok
9.159.2798 Boehringer Ingelheim Investigational Site
Bangkok
9.159.2799 Boehringer Ingelheim Investigational Site
Bangkok
9.159.2800 Boehringer Ingelheim Investigational Site
Bangkok
9.159.2801 Boehringer Ingelheim Investigational Site
Chiang Mai

Other trials in Thailand

Portugal4 sites

9.159.2040 Hospital Fernando Fonseca
Amadora
9.159.2039 Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra
9.159.2041 Centro Hospitalar de Lisboa Norte
Lisbon
9.159.2042 Centro Hospitalar do Porto
Porto

Other trials in Portugal

Norway3 sites

9.159.2029 Boehringer Ingelheim Investigational Site
Bergen
9.159.2028 Boehringer Ingelheim Investigational Site
Oslo
9.159.2027 Boehringer Ingelheim Investigational Site
Trondheim

Other trials in Norway

Singapore3 sites

9.159.2703 Boehringer Ingelheim Investigational Site
Singapore
9.159.2704 Boehringer Ingelheim Investigational Site
Singapore
9.159.2705 Boehringer Ingelheim Investigational Site
Singapore

Other trials in Singapore

Brazil2 sites

9.159.2869 Complexo Hospitalar Universitario Prof Edgard Santos
Salvador
9.159.2853 Boehringer Ingelheim Investigational Site
São Paulo

Other trials in Brazil

Hong Kong2 sites

9.159.2713 Boehringer Ingelheim Investigational Site
Hong Kong
9.159.2714 Boehringer Ingelheim Investigational Site
Hong Kong

Other trials in Hong Kong

Ireland2 sites

9.159.1851 Boehringer Ingelheim Investigational Site
Cork
9.159.1852 Boehringer Ingelheim Investigational Site
Dublin

Other trials in Ireland

Malaysia2 sites

9.159.2707 Boehringer Ingelheim Investigational Site
Kelantan Darul Naim
9.159.2706 Boehringer Ingelheim Investigational Site
Kuala Lumpur

Other trials in Malaysia

El Salvador1 site

9.159.2181 Boehringer Ingelheim Investigational Site
Oviedo

Other trials in El Salvador

Mexico1 site

9.159.2765 Boehringer Ingelheim Investigational Site
Metepec

Other trials in Mexico

About this study

Official title: PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis

Conditions: Stroke
Being tested: Aggrenox, Clopidogrel placebo, Micardis, Aggrenox placebo, Clopidogrel
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AggrenoxDrug
25mg aspirin, 200 mg dipyridamole
AggrenoxDrug
25mg aspirin, 200 mg dipyridamole
Clopidogrel placeboDrug
placebo
Clopidogrel placeboDrug
placebo
MicardisDrug
80 mg micardis
MicardisDrug
80 mg micardis
Aggrenox placeboDrug
placebo
Aggrenox placeboDrug
placebo
ClopidogrelDrug
75 mg clopidogrel
ClopidogrelDrug
75 mg clopidogrel
Micardis placeboDrug
placebo
Micardis placeboDrug
placebo

Study groups in NCT00153062
Study group	Role	What they receive
Aggrenox, Clopidogrel placebo, Micardis	Placebo comparator	Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd Receives: Drug: Aggrenox; Drug: Clopidogrel placebo; Drug: Micardis
Aggrenox placebo, clopidogrel,, Micardis	Placebo comparator	Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd Receives: Drug: Micardis; Drug: Aggrenox placebo; Drug: Clopidogrel
Aggrenox, clop placebo, micardis placebo	Placebo comparator	Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd Receives: Drug: Aggrenox; Drug: Clopidogrel placebo; Drug: Micardis placebo
Aggrenox plcebo, clop, micardis placebo	Placebo comparator	Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd. Receives: Drug: Aggrenox placebo; Drug: Clopidogrel; Drug: Micardis placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)
Measured: time since randomization; follow-up period is 1.5 to 4.4 years
Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)
Measured: time since randomization; follow-up period is 1.5 to 4.4 years

Secondary outcomes (3)

Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)
Number of patients with any of stroke, myocardial infarction, vascular death
Measured: time since randomization; follow-up period is 1.5 to 4.4 years
Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)
Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure
Measured: time since randomization; follow-up period is 1.5 to 4.4 years
Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)
Measured: Randomization to final patient contact

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2003Apr 2008

First posted12 Sep 2005 (estimated)
Study startAug 2003
Primary completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 20,332 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00153062
Sponsor's protocol ID: 9.159
Status last verified: Apr 2014
First submitted: 9 Sep 2005
Last updated: 13 May 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Ovbiagele B, Bath PM, Cotton D, Sha N, Diener HC; PRoFESS Investigators. Low glomerular filtration rate, recurrent stroke risk, and effect of renin-angiotensin system modulation. Stroke. 2013 Nov;44(11):3223-5. doi: 10.1161/STROKEAHA.113.002463. Epub 2013 Aug 29.
PubMed 23988639
Bohm M, Cotton D, Foster L, Custodis F, Laufs U, Sacco R, Bath PM, Yusuf S, Diener HC. Impact of resting heart rate on mortality, disability and cognitive decline in patients after ischaemic stroke. Eur Heart J. 2012 Nov;33(22):2804-12. doi: 10.1093/eurheartj/ehs250. Epub 2012 Aug 26.
PubMed 22922507
Weber R, Weimar C, Blatchford J, Hermansson K, Wanke I, Moller-Hartmann C, Gizewski ER, Forsting M, Demchuk AM, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Telmisartan on top of antihypertensive treatment does not prevent progression of cerebral white matter lesions in the prevention regimen for effectively avoiding second strokes (PRoFESS) MRI substudy. Stroke. 2012 Sep;43(9):2336-42. doi: 10.1161/STROKEAHA.111.648576. Epub 2012 Jun 26.
PubMed 22738922
Weber R, Weimar C, Wanke I, Moller-Hartmann C, Gizewski ER, Blatchford J, Hermansson K, Demchuk AM, Forsting M, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Risk of recurrent stroke in patients with silent brain infarction in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) imaging substudy. Stroke. 2012 Feb;43(2):350-5. doi: 10.1161/STROKEAHA.111.631739. Epub 2012 Jan 19.
PubMed 22267825
Ovbiagele B, Diener HC, Yusuf S, Martin RH, Cotton D, Vinisko R, Donnan GA, Bath PM; PROFESS Investigators. Level of systolic blood pressure within the normal range and risk of recurrent stroke. JAMA. 2011 Nov 16;306(19):2137-44. doi: 10.1001/jama.2011.1650.
PubMed 22089721
Diener HC, Sacco RL, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) study group. Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study. Lancet Neurol. 2008 Oct;7(10):875-84. doi: 10.1016/S1474-4422(08)70198-4. Epub 2008 Aug 29.
PubMed 18757238
Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.
PubMed 18753639
Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, Vandermaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.
PubMed 18753638

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis
ClinicalTrials.gov ID: NCT00153062
Acronym / sponsor ID: 9.159
Conditions: Stroke
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20,332 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline, Bayer
Study start: Aug 2003
Primary completion: Apr 2008 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 2 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
Aggrenox, Clopidogrel placebo, Micardis	Placebo comparator	Drug: Aggrenox, Drug: Clopidogrel placebo, Drug: MicardisAggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
Aggrenox placebo, clopidogrel,, Micardis	Placebo comparator	Drug: Micardis, Drug: Aggrenox placebo, Drug: ClopidogrelClopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
Aggrenox, clop placebo, micardis placebo	Placebo comparator	Drug: Aggrenox, Drug: Clopidogrel placebo, Drug: Micardis placeboAggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
Aggrenox plcebo, clop, micardis placebo	Placebo comparator	Drug: Aggrenox placebo, Drug: Clopidogrel, Drug: Micardis placeboClopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors:
Diabetes mellitus
Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)
Smoker at time of qualifying stroke
Obesity (BMI>30; BMI=weight (kg)/[height (m)]2)

Key exclusion criteria (1 listed)

hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding ;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of dementia;modified Rankin score greater than 4;qualifying stroke induced by surgical or cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmHg (goal BPs are lower); SBP 120 mmHg or less for hospitalized patients; currently taking an ARB and not able or willing to switch to alternative; required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial; history of thrombocytopenia or neutropenia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aggrenox25mg aspirin, 200 mg dipyridamole	Drug	Aggrenox, Clopidogrel placebo, Micardis
Aggrenox25mg aspirin, 200 mg dipyridamole	Drug	Aggrenox, clop placebo, micardis placebo
Clopidogrel placeboplacebo	Drug	Aggrenox, Clopidogrel placebo, Micardis
Clopidogrel placeboplacebo	Drug	Aggrenox, clop placebo, micardis placebo
Micardis80 mg micardis	Drug	Aggrenox, Clopidogrel placebo, Micardis
Micardis80 mg micardis	Drug	Aggrenox placebo, clopidogrel,, Micardis
Aggrenox placeboplacebo	Drug	Aggrenox placebo, clopidogrel,, Micardis
Aggrenox placeboplacebo	Drug	Aggrenox plcebo, clop, micardis placebo
Clopidogrel75 mg clopidogrel	Drug	Aggrenox placebo, clopidogrel,, Micardis
Clopidogrel75 mg clopidogrel	Drug	Aggrenox plcebo, clop, micardis placebo
Micardis placeboplacebo	Drug	Aggrenox, clop placebo, micardis placebo
Micardis placeboplacebo	Drug	Aggrenox plcebo, clop, micardis placebo

Primary outcome

Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)
Time frame: time since randomization; follow-up period is 1.5 to 4.4 years
Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)
Time frame: time since randomization; follow-up period is 1.5 to 4.4 years

3 secondary outcomes

Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)
Time frame: time since randomization; follow-up period is 1.5 to 4.4 years
Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)
Time frame: time since randomization; follow-up period is 1.5 to 4.4 years
Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)
Time frame: Randomization to final patient contact

Results and safety

Results posted to the registry on 2 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aspirin + Extended Release Dipyridamole / Telmisartan	5,086	4,699
Aspirin + Extended Release Dipyridamole / Placebo	5,095	4,689
Clopidogrel / Telmisartan	5,060	4,645
Clopidogrel / Placebo	5,091	4,680

Primary outcome: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)

Time frame: time since randomization; follow-up period is 1.5 to 4.4 years. Number. Unit: Participants

Measure	Aspirin + Extended Release Dipyridamole n = 10181	Clopidogrel n = 10151
Value	916	898

Aspirin + Extended Release Dipyridamole vs Clopidogrel: Hazard Ratio (HR): 1.01 (95% CI 0.92 to 1.11), p = 0.7830, Cox Proportional Hazard model

Population analysed: Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.

Primary outcome: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)

Time frame: time since randomization; follow-up period is 1.5 to 4.4 years. Number. Unit: Participants

Measure	Telmisartan n = 10146	Placebo n = 10186
Value	880	934

Telmisartan vs Placebo: Hazard Ratio (HR): 0.95 (95% CI 0.86 to 1.04), p = 0.2312, Cox Proportional Hazard model

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day of first dose until 28 days after last dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aspirin + Extended Release Dipyridamole / Telmisartan	1,145 of ?	1,856 of ?	Not reported
Aspirin + Extended Release Dipyridamole / Placebo	1,124 of ?	1,810 of ?	Not reported
Clopidogrel / Telmisartan	1,225 of ?	866 of ?	Not reported
Clopidogrel / Placebo	1,163 of ?	810 of ?	Not reported

Limitations and caveats (from the sponsor): All SAEs and AEs that led to temporary or permanent trial drug discontinuation were reported, except in Japan, where all AEs were collected. Protocol-defined outcome events were not reported as AEs, but were recorded on the appropriate form

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23988639Ovbiagele B, Bath PM, Cotton D, Sha N, Diener HC; PRoFESS Investigators. Low glomerular filtration rate, recurrent stroke risk, and effect of renin-angiotensin system modulation. Stroke. 2013 Nov;44(11):3223-5. doi: 10.1161/STROKEAHA.113.002463. Epub 2013 Aug 29.
Derived from this study: PubMed 22922507Bohm M, Cotton D, Foster L, Custodis F, Laufs U, Sacco R, Bath PM, Yusuf S, Diener HC. Impact of resting heart rate on mortality, disability and cognitive decline in patients after ischaemic stroke. Eur Heart J. 2012 Nov;33(22):2804-12. doi: 10.1093/eurheartj/ehs250. Epub 2012 Aug 26.
Derived from this study: PubMed 22738922Weber R, Weimar C, Blatchford J, Hermansson K, Wanke I, Moller-Hartmann C, Gizewski ER, Forsting M, Demchuk AM, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Telmisartan on top of antihypertensive treatment does not prevent progression of cerebral white matter lesions in the prevention regimen for effectively avoiding second strokes (PRoFESS) MRI substudy. Stroke. 2012 Sep;43(9):2336-42. doi: 10.1161/STROKEAHA.111.648576. Epub 2012 Jun 26.
Derived from this study: PubMed 22267825Weber R, Weimar C, Wanke I, Moller-Hartmann C, Gizewski ER, Blatchford J, Hermansson K, Demchuk AM, Forsting M, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Risk of recurrent stroke in patients with silent brain infarction in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) imaging substudy. Stroke. 2012 Feb;43(2):350-5. doi: 10.1161/STROKEAHA.111.631739. Epub 2012 Jan 19.
Derived from this study: PubMed 22089721Ovbiagele B, Diener HC, Yusuf S, Martin RH, Cotton D, Vinisko R, Donnan GA, Bath PM; PROFESS Investigators. Level of systolic blood pressure within the normal range and risk of recurrent stroke. JAMA. 2011 Nov 16;306(19):2137-44. doi: 10.1001/jama.2011.1650.
Derived from this study: PubMed 18757238Diener HC, Sacco RL, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) study group. Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study. Lancet Neurol. 2008 Oct;7(10):875-84. doi: 10.1016/S1474-4422(08)70198-4. Epub 2008 Aug 29.
Derived from this study: PubMed 18753639Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.
Derived from this study: PubMed 18753638Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, Vandermaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.

Related trials for Stroke

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

667 sites in 36 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aggrenox, Micardis and Clopidogrel in people with Stroke, run by Boehringer Ingelheim at 667 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 667 sites in United States, Canada, Russia, Japan, China and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time frame: time since randomization; follow-up period is 1.5 to 4.4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00153062, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.