AzTrials
AzTrials

Atrial FibrillationPhase 3BOREALIS-AFNCT00580216

Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

A Phase 3 study testing Idrabiotaparinux sodium, Warfarin and Avidin in people with Atrial Fibrillation, run by Sanofi at 538 sites in 48 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Idrabiotaparinux sodium, Warfarin and Avidin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,773 participants
Where
538 sitesin 48 countries
Study dates
Dec 2007to Oct 2010
Phase
Phase 3
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non valvular atrial fibrillation (AF)
  • Indication for long-term Vitamin-K antagonist (VKA) therapy based on the presence of previous ischemic stroke, transient ischemic attack (TIA) or systemic embolism and/or at least two of the following risk factors: hypertension requiring drug treatment, moderately or severely impaired left ventricular function and/or congestive heart failure, age > or = 75 years, diabetes mellitus.
  • Main exclusion Criteria:
  • Indication for VKA other than AF
  • Stroke or TIA within previous 5 days
  • Transient AF caused by a reversible disorder
Show all 11Show fewer
  • Planned major surgery/trauma or cardioversion within 30 days
  • INR > 3 at baseline
  • Active bleeding or high risk of bleeding
  • Uncontrolled hypertension
  • Pregnancy or childbearing potential without proper contraceptive measures or breast feeding.

Who cannot join

None listed.

Trial locations and contacts

538 sites in 48 countries.

538 sites in 48 countries

United States162 sites

  • Sanofi-Aventis Investigational Site Number 840047

    Alexandria, Louisiana, SUITE 250

  • Sanofi-Aventis Investigational Site Number 840311

    Alpena, Michigan, 49707

  • Sanofi-Aventis Investigational Site Number 840076

    Amarillo, Texas, 79106

  • Sanofi-Aventis Investigational Site Number 840096

    Anaconda, Montana, 59711

  • Sanofi-Aventis Investigational Site Number 840261

    Anderson, South Carolina, 29621

  • Sanofi-Aventis Investigational Site Number 840297

    Anderson, South Carolina, 29621

  • Sanofi-Aventis Investigational Site Number 840062

    Athens, Tennessee, 37303

  • Sanofi-Aventis Investigational Site Number 840073

    Atlanta, Georgia, 30342

  • Sanofi-Aventis Investigational Site Number 840145

    Auburn, Maine, 04210

  • Sanofi-Aventis Investigational Site Number 840273

    Augusta, Georgia, 30909

  • Sanofi-Aventis Investigational Site Number 840017

    Baltimore, Maryland, 21237

  • Sanofi-Aventis Investigational Site Number 840246

    Bay Pines, Florida, 33744

  • Sanofi-Aventis Investigational Site Number 840066

    Beach, Florida, 32168

  • Sanofi-Aventis Investigational Site Number 840280

    Beaver City, Indiana, 15009

  • Sanofi-Aventis Investigational Site Number 840256

    Beloit, Wisconsin, 53511

  • Sanofi-Aventis Investigational Site Number 840113

    Bend, Oregon, 97701

  • Sanofi-Aventis Investigational Site Number 840270

    Beverly Hills, California, 90210

  • Sanofi-Aventis Investigational Site Number 840278

    Beverly Hills, California, 90211

  • Sanofi-Aventis Investigational Site Number 840313

    Brandon, Florida, 33511

  • Sanofi-Aventis Investigational Site Number 840268

    Bridgeport, Connecticut, 06610

  • Sanofi-Aventis Investigational Site Number 840276

    Brighton, Michigan, 48114

  • Sanofi-Aventis Investigational Site Number 840048

    Bristol, Tennessee, 37620

  • Sanofi-Aventis Investigational Site Number 840052

    Bristol, Tennessee, 37620

  • Sanofi-Aventis Investigational Site Number 840102

    Buffalo, New York, 14209

  • Sanofi-Aventis Investigational Site Number 840241

    Burbank, California, 91505

  • Sanofi-Aventis Investigational Site Number 840008

    Butte, Montana, 59701

  • Sanofi-Aventis Investigational Site Number 840172

    Camden, South Carolina, 29020

  • Sanofi-Aventis Investigational Site Number 840197

    Centerville, Ohio, 45459

  • Sanofi-Aventis Investigational Site Number 840221

    Chicago, Illinois, 60637

  • Sanofi-Aventis Investigational Site Number 840206

    Chicago, Illinois, 60664

  • Sanofi-Aventis Investigational Site Number 840074

    Cincinnati, Ohio, 45267-0525

  • Sanofi-Aventis Investigational Site Number 840146

    Cleveland, Ohio, 44109

  • Sanofi-Aventis Investigational Site Number 840104

    Cleveland, Tennessee, 37312

  • Sanofi-Aventis Investigational Site Number 840223

    Clinton, Utah, 84015

  • Sanofi-Aventis Investigational Site Number 840168

    Columbia, South Carolina, 29201

  • Sanofi-Aventis Investigational Site Number 840204

    Columbus, Georgia, 31904-5245

  • Sanofi-Aventis Investigational Site Number 840290

    Columbus, Georgia, 31904

  • Sanofi-Aventis Investigational Site Number 840225

    Columbus, Georgia, 31907

  • Sanofi-Aventis Investigational Site Number 840010

    Corona, California, 92879

  • Sanofi-Aventis Investigational Site Number 840252

    Corsicana, Texas, 75110

  • Sanofi-Aventis Investigational Site Number 840248

    Cranston, Rhode Island, 02920

  • Sanofi-Aventis Investigational Site Number 840317

    Denton, Maryland, 76201

  • Sanofi-Aventis Investigational Site Number 840242

    Detroit, Michigan, 48236

  • Sanofi-Aventis Investigational Site Number 840084

    Dunnellon, Florida, 34432

  • Sanofi-Aventis Investigational Site Number 840305

    Dunwoody, Georgia, 30338

  • Sanofi-Aventis Investigational Site Number 840014

    Elkhart, Indiana, 46514

  • Sanofi-Aventis Investigational Site Number 840195

    Encino, California, 91436

  • Sanofi-Aventis Investigational Site Number 840058

    Everett, Washington, 98201

  • Sanofi-Aventis Investigational Site Number 840020

    Fargo, North Dakota, 58103

  • Sanofi-Aventis Investigational Site Number 840138

    Fort Lauderdale, Florida, 33308

  • Sanofi-Aventis Investigational Site Number 840220

    Fort Lauderdale, Florida, 33316

  • Sanofi-Aventis Investigational Site Number 840032

    Fort Meade, South Dakota, 57741

  • Sanofi-Aventis Investigational Site Number 840126

    Fremont, Nebraska, 68025

  • Sanofi-Aventis Investigational Site Number 840215

    Gainesville, Florida, 32608

  • Sanofi-Aventis Investigational Site Number 840292

    Gallipolis, Ohio, 45631

  • Sanofi-Aventis Investigational Site Number 840253

    Grand Rapids, Michigan, 49503

  • Sanofi-Aventis Investigational Site Number 840277

    Greensboro, North Carolina, 27401

  • Sanofi-Aventis Investigational Site Number 840196

    Greensboro, North Carolina, 27408

  • Sanofi-Aventis Investigational Site Number 840067

    Gulfport, Mississippi, 39503

  • Sanofi-Aventis Investigational Site Number 840303

    Hamilton, New Jersey, 08690

  • Sanofi-Aventis Investigational Site Number 840127

    Hickory, North Carolina, 28602

  • Sanofi-Aventis Investigational Site Number 840131

    Hollywood, Florida, 33021

  • Sanofi-Aventis Investigational Site Number 840161

    Hollywood, Florida, 33021

  • Sanofi-Aventis Investigational Site Number 840286

    Houston, Texas, 77070

  • Sanofi-Aventis Investigational Site Number 840130

    Idaho Falls, Idaho, 83404

  • Sanofi-Aventis Investigational Site Number 840228

    Idaho Falls, Idaho, 83404

  • Sanofi-Aventis Investigational Site Number 840304

    Indiana, Pennsylvania, 15701

  • Sanofi-Aventis Investigational Site Number 840132

    Irving, Texas, 75061

  • Sanofi-Aventis Investigational Site Number 840218

    Jena, Louisiana, 71342

  • Sanofi-Aventis Investigational Site Number 840152

    Johnson City, New York, 13790

  • Sanofi-Aventis Investigational Site Number 840129

    Johnson City, Tennessee, 37614

  • Sanofi-Aventis Investigational Site Number 840234

    Key West, Florida, 33040

  • Sanofi-Aventis Investigational Site Number 840247

    Lafayette, Louisiana, 70503

  • Sanofi-Aventis Investigational Site Number 840158

    Lake Charles, Louisiana, 70601

  • Sanofi-Aventis Investigational Site Number 840112

    Lake Mary, Florida, 32746

  • Sanofi-Aventis Investigational Site Number 840053

    Lakeland, Florida, 33805

  • Sanofi-Aventis Investigational Site Number 840051

    Las Vegas, Nevada, 89119

  • Sanofi-Aventis Investigational Site Number 840258

    Las Vegas, Nevada, 89144

  • Sanofi-Aventis Investigational Site Number 840265

    Lexington, Kentucky, 40504

  • Sanofi-Aventis Investigational Site Number 840109

    Linden, New Jersey, 07036

  • Sanofi-Aventis Investigational Site Number 840255

    Little Rock, Arkansas, 72204

  • Sanofi-Aventis Investigational Site Number 840224

    Little Rock, Arkansas, 72205

  • Sanofi-Aventis Investigational Site Number 840033

    Loma Linda, California, 92354

  • Sanofi-Aventis Investigational Site Number 840184

    Long Beach, California, 90813

  • Sanofi-Aventis Investigational Site Number 840183

    Los Banos, California, 93635

  • Sanofi-Aventis Investigational Site Number 840293

    Madison, Wisconsin, 53713

  • Sanofi-Aventis Investigational Site Number 840122

    Manning, South Carolina, 29102

  • Sanofi-Aventis Investigational Site Number 840026

    Mason, Ohio, 45040

  • Sanofi-Aventis Investigational Site Number 840198

    Melbourne, Florida, 32901

  • Sanofi-Aventis Investigational Site Number 840117

    Miami, Florida, 33156

  • Sanofi-Aventis Investigational Site Number 840227

    Mobile, Alabama, 36608

  • Sanofi-Aventis Investigational Site Number 840024

    Morristown, New Jersey, 07962-1956

  • Sanofi-Aventis Investigational Site Number 840179

    Mountain Home, Arkansas, 72653

  • Sanofi-Aventis Investigational Site Number 840143

    Nampa, Idaho, 83686

  • Sanofi-Aventis Investigational Site Number 840269

    Nashville, Tennessee, 37203

  • Sanofi-Aventis Investigational Site Number 840077

    Natchitoches, Louisiana, 71457

  • Sanofi-Aventis Investigational Site Number 840085

    Newberry, South Carolina, 29108

  • Sanofi-Aventis Investigational Site Number 840003

    Niceville, Florida, 32578

  • Sanofi-Aventis Investigational Site Number 840272

    Northridge, California, 91325

  • Sanofi-Aventis Investigational Site Number 840230

    Ocala, Florida, 34471

  • Sanofi-Aventis Investigational Site Number 840005

    Odessa, Texas, 79761

  • Sanofi-Aventis Investigational Site Number 840289

    Odessa, Texas, 79761

  • Sanofi-Aventis Investigational Site Number 840045

    Oklahoma City, Oklahoma, 73104

  • Sanofi-Aventis Investigational Site Number 840213

    Orange, California, 92868

  • Sanofi-Aventis Investigational Site Number 840202

    Orlando, Florida, 32803

  • Sanofi-Aventis Investigational Site Number 840306

    Orlando, Florida, 32822

  • Sanofi-Aventis Investigational Site Number 840022

    Ormond Beach, Florida, 32174

  • Sanofi-Aventis Investigational Site Number 840110

    Palm Harbor, Florida, 34684

  • Sanofi-Aventis Investigational Site Number 840189

    Pelzer, South Carolina, 29669

  • Sanofi-Aventis Investigational Site Number 840128

    Philadelphia, Pennsylvania, 19102

  • Sanofi-Aventis Investigational Site Number 840160

    Philadelphia, Pennsylvania, 19143

  • Sanofi-Aventis Investigational Site Number 840339

    Philadelphia, Pennsylvania, 19149

  • Sanofi-Aventis Investigational Site Number 840006

    Picayune, Mississippi, 39466

  • Sanofi-Aventis Investigational Site Number 840181

    Pittsburgh, Pennsylvania, 15240

  • Sanofi-Aventis Investigational Site Number 840211

    Plantation, Florida, 33317

  • Sanofi-Aventis Investigational Site Number 840257

    Portland, Oregon, 97220

  • Sanofi-Aventis Investigational Site Number 840150

    Raleigh, North Carolina, 27615

  • Sanofi-Aventis Investigational Site Number 840009

    Redondo Beach, California, 90277

  • Sanofi-Aventis Investigational Site Number 840298

    Riverside, California, 92501

  • Sanofi-Aventis Investigational Site Number 840159

    Rochester, New York, 14607

  • Sanofi-Aventis Investigational Site Number 840185

    Rocky Mount, North Carolina, 27804

  • Sanofi-Aventis Investigational Site Number 840137

    Saint Clair Shores, Michigan, 48081

  • Sanofi-Aventis Investigational Site Number 840134

    Saint Cloud, Minnesota, 56303

  • Sanofi-Aventis Investigational Site Number 840068

    Salem, Virginia, 24153

  • Sanofi-Aventis Investigational Site Number 840238

    Salt Lake City, Utah, 84124

  • Sanofi-Aventis Investigational Site Number 840308

    Salt Lake City, Utah, 84124

  • Sanofi-Aventis Investigational Site Number 840186

    San Antonio, Texas, 78234

  • Sanofi-Aventis Investigational Site Number 840194

    San Antonio, Texas, 78238

  • Sanofi-Aventis Investigational Site Number 840264

    San Diego, California, 92103

  • Sanofi-Aventis Investigational Site Number 840275

    San Diego, California, 92128

  • Sanofi-Aventis Investigational Site Number 840116

    Sanford, Florida, 32271

  • Sanofi-Aventis Investigational Site Number 840103

    Santa Ana, California, 92704

  • Sanofi-Aventis Investigational Site Number 840002

    Santa Rosa, California, 95405

  • Sanofi-Aventis Investigational Site Number 840165

    Savannah, Georgia, 31405

  • Sanofi-Aventis Investigational Site Number 840229

    Scotland, Pennsylvania, 17254

  • Sanofi-Aventis Investigational Site Number 840123

    Seattle, Washington, 98111

  • Sanofi-Aventis Investigational Site Number 840259

    Shreveport, Louisiana, 71103

  • Sanofi-Aventis Investigational Site Number 840231

    Shreveport, Louisiana, 71105

  • Sanofi-Aventis Investigational Site Number 840232

    Shreveport, Louisiana, 71105

  • Sanofi-Aventis Investigational Site Number 840243

    Spring Hill, Florida, 34609

  • Sanofi-Aventis Investigational Site Number 840219

    Springfield, Virginia, 22151

  • Sanofi-Aventis Investigational Site Number 840201

    St Louis, Missouri, 63104

  • Sanofi-Aventis Investigational Site Number 840310

    St Louis, Missouri, 63122

  • Sanofi-Aventis Investigational Site Number 840200

    St Louis, Missouri, 63128

  • Sanofi-Aventis Investigational Site Number 840323

    St Louis, Missouri, 63141

  • Sanofi-Aventis Investigational Site Number 840082

    St. Petersburg, Florida, 33701

  • Sanofi-Aventis Investigational Site Number 840012

    St. Petersburg, Florida, 33707

  • Sanofi-Aventis Investigational Site Number 840072

    Stoneboro, Pennsylvania, 16153

  • Sanofi-Aventis Investigational Site Number 840019

    Tacoma, Washington, 98405

  • Sanofi-Aventis Investigational Site Number 840236

    Temple, Texas, 76508

  • Sanofi-Aventis Investigational Site Number 840284

    The Bronx, New York

  • Sanofi-Aventis Investigational Site Number 840233

    Toledo, Ohio, 43608

  • Sanofi-Aventis Investigational Site Number 840111

    Torrance, California, 90505

  • Sanofi-Aventis Investigational Site Number 840209

    Tucson, Arizona, 85723

  • Sanofi-Aventis Investigational Site Number 840133

    Tulsa, Oklahoma, 74104

  • Sanofi-Aventis Investigational Site Number 840011

    Victoria, Texas, 77901

  • Sanofi-Aventis Investigational Site Number 840118

    Visalia, California, 93291

  • Sanofi-Aventis Investigational Site Number 840064

    Wadsworth, Ohio, 44281

  • Sanofi-Aventis Investigational Site Number 840282

    Wauwatosa, Wisconsin, 53226

  • Sanofi-Aventis Investigational Site Number 840056

    Westfield, New York, 14787

  • Sanofi-Aventis Investigational Site Number 840249

    Wichita, Kansas, 67208

  • Sanofi-Aventis Investigational Site Number 840285

    Wichita Falls, Texas, 76309

Other trials in United States

Russia54 sites

  • Sanofi-Aventis Investigational Site Number 643033

    Barnaul, 656055

  • Sanofi-Aventis Investigational Site Number 643040

    Chelyabinsk, 454048

  • Sanofi-Aventis Investigational Site Number 643050

    Chelyabinsk, 454092

  • Sanofi-Aventis Investigational Site Number 643036

    Chelyabinsk, 454136

  • Sanofi-Aventis Investigational Site Number 643009

    Kemerovo, 650002

  • Sanofi-Aventis Investigational Site Number 643042

    Kemerovo, 650002

  • Sanofi-Aventis Investigational Site Number 643015

    Moscow, 105066

  • Sanofi-Aventis Investigational Site Number 643032

    Moscow, 109263

  • Sanofi-Aventis Investigational Site Number 643007

    Moscow, 111539

  • Sanofi-Aventis Investigational Site Number 643020

    Moscow, 117292

  • Sanofi-Aventis Investigational Site Number 643054

    Moscow, 117342

  • Sanofi-Aventis Investigational Site Number 643052

    Moscow, 117556

  • Sanofi-Aventis Investigational Site Number 643056

    Moscow, 119415

  • Sanofi-Aventis Investigational Site Number 643025

    Moscow, 119435

  • Sanofi-Aventis Investigational Site Number 643053

    Moscow, 119435

  • Sanofi-Aventis Investigational Site Number 643028

    Moscow, 121359

  • Sanofi-Aventis Investigational Site Number 643037

    Moscow, 121359

  • Sanofi-Aventis Investigational Site Number 643001

    Moscow, 121552

  • Sanofi-Aventis Investigational Site Number 643026

    Moscow, 121552

  • Sanofi-Aventis Investigational Site Number 643039

    Moscow, 121552

  • Sanofi-Aventis Investigational Site Number 643011

    Moscow, 127473

  • Sanofi-Aventis Investigational Site Number 643034

    Moscow, 127473

  • Sanofi-Aventis Investigational Site Number 643049

    Moscow, 129090

  • Sanofi-Aventis Investigational Site Number 643030

    Moscow, 129336

  • Sanofi-Aventis Investigational Site Number 643013

    Nizhny Novgorod, 603003

  • Sanofi-Aventis Investigational Site Number 643041

    Nizniy Novgorod, 603005

  • Sanofi-Aventis Investigational Site Number 643051

    Novosibirsk, 630008

  • Sanofi-Aventis Investigational Site Number 643044

    Novosibirsk, 630091

  • Sanofi-Aventis Investigational Site Number 643048

    Novosibirsk-117, 630117

  • Sanofi-Aventis Investigational Site Number 643045

    Penza

  • Sanofi-Aventis Investigational Site Number 643023

    Perm, 614097

  • Sanofi-Aventis Investigational Site Number 643006

    Perm, 614107

  • Sanofi-Aventis Investigational Site Number 643046

    Petrozavodsk, 185019

  • Sanofi-Aventis Investigational Site Number 643012

    Rostov-on-Don, 344068

  • Sanofi-Aventis Investigational Site Number 643008

    Ryazan, 390026

  • Sanofi-Aventis Investigational Site Number 643022

    Saint Petersburg, 192242

  • Sanofi-Aventis Investigational Site Number 643038

    Saint Petersburg, 194354

  • Sanofi-Aventis Investigational Site Number 643016

    Saint Petersburg, 196247

  • Sanofi-Aventis Investigational Site Number 643017

    Saint Petersburg, 197022

  • Sanofi-Aventis Investigational Site Number 643047

    Saint Petersburg, 197022

  • Sanofi-Aventis Investigational Site Number 643018

    Saint Petersburg, 197110

  • Sanofi-Aventis Investigational Site Number 643010

    Saint Petersburg, 198013

  • Sanofi-Aventis Investigational Site Number 643027

    Saint Petersburg, 198013

  • Sanofi-Aventis Investigational Site Number 643002

    Saint Petersburg, 199106

  • Sanofi-Aventis Investigational Site Number 643029

    Samara, 443070

  • Sanofi-Aventis Investigational Site Number 643004

    Saratov, 410028

  • Sanofi-Aventis Investigational Site Number 643005

    Saratov, 410028

  • Sanofi-Aventis Investigational Site Number 643003

    Saratov, 410054

  • Sanofi-Aventis Investigational Site Number 643024

    Tomsk, 634012

  • Sanofi-Aventis Investigational Site Number 643035

    Tomsk, 634012

  • Sanofi-Aventis Investigational Site Number 643021

    Tyumen, 625023

  • Sanofi-Aventis Investigational Site Number 643043

    Voronezh, 394006

  • Sanofi-Aventis Investigational Site Number 643019

    Yaroslavl, 150062

  • Sanofi-Aventis Investigational Site Number 643031

    Yekaterinburg, 620109

Other trials in Russia

France26 sites

  • Sanofi-Aventis Investigational Site Number 250028

    Abbeville, 80142

  • Sanofi-Aventis Investigational Site Number 250012

    Albi, 81013

  • Sanofi-Aventis Investigational Site Number 250034

    Allauch, 13190

  • Sanofi-Aventis Investigational Site Number 250031

    Belfort, 90016

  • Sanofi-Aventis Investigational Site Number 250011

    Bordeaux, 33076

  • Sanofi-Aventis Investigational Site Number 250010

    Brest, 29609

  • Sanofi-Aventis Investigational Site Number 250021

    Brest, 29609

  • Sanofi-Aventis Investigational Site Number 250035

    Bron, 69677

  • Sanofi-Aventis Investigational Site Number 250022

    Cholet, 49300

  • Sanofi-Aventis Investigational Site Number 250006

    Dijon, 21033

  • Sanofi-Aventis Investigational Site Number 250018

    Dijon, 21034

  • Sanofi-Aventis Investigational Site Number 250004

    La Rochelle, 17019

  • Sanofi-Aventis Investigational Site Number 250029

    Le Chesnay, 78187

  • Sanofi-Aventis Investigational Site Number 250019

    Lille, 59020

  • Sanofi-Aventis Investigational Site Number 250015

    Lille, 59037

  • Sanofi-Aventis Investigational Site Number 250030

    Metz-Tessy, 74370

  • Sanofi-Aventis Investigational Site Number 250003

    Montpellier, 34295

  • Sanofi-Aventis Investigational Site Number 250032

    Montpellier, 59523

  • Sanofi-Aventis Investigational Site Number 250016

    Nice, 06006

  • Sanofi-Aventis Investigational Site Number 250001

    Paris, 75018

  • Sanofi-Aventis Investigational Site Number 250014

    Paris, 75651

  • Sanofi-Aventis Investigational Site Number 250008

    Paris, 75674

  • Sanofi-Aventis Investigational Site Number 250005

    Saint-Etienne, 42055

  • Sanofi-Aventis Investigational Site Number 250026

    Toulouse, 31059

  • Sanofi-Aventis Investigational Site Number 250027

    Tours, 37044

  • Sanofi-Aventis Investigational Site Number 250002

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Netherlands25 sites

  • Sanofi-Aventis Investigational Site Number 528012

    Almelo, 7609 PP

  • Sanofi-Aventis Investigational Site Number 528030

    Amsterdam, 1066 EC

  • Sanofi-Aventis Investigational Site Number 528026

    Breda, 4818 CK

  • Sanofi-Aventis Investigational Site Number 528009

    Delft, 2526 AD

  • Sanofi-Aventis Investigational Site Number 528027

    Ede, 6716 RP

  • Sanofi-Aventis Investigational Site Number 528006

    Eindhoven, 5623 EJ

  • Sanofi-Aventis Investigational Site Number 528017

    Eindhoven, 5623 EJ

  • Sanofi-Aventis Investigational Site Number 528016

    Gouda, 2803 HH

  • Sanofi-Aventis Investigational Site Number 528007

    Harderwijk, 3844 DG

  • Sanofi-Aventis Investigational Site Number 528001

    Heerlen, 6419 PC

  • Sanofi-Aventis Investigational Site Number 528024

    Heerlen, 6419 PC

  • Sanofi-Aventis Investigational Site Number 528003

    Hengelo, 7555 DL

  • Sanofi-Aventis Investigational Site Number 528010

    Hengelo, 7555 DL

  • Sanofi-Aventis Investigational Site Number 528031

    Hoogeveen, 7909 AA

  • Sanofi-Aventis Investigational Site Number 528019

    Hoorn, 1625 HV

  • Sanofi-Aventis Investigational Site Number 528020

    Leeuwarden, 8934 AD

  • Sanofi-Aventis Investigational Site Number 528004

    Nijmegen, 6532 SZ

  • Sanofi-Aventis Investigational Site Number 528013

    Rotterdam, 3083 AN

  • Sanofi-Aventis Investigational Site Number 528022

    Sittard-Geleen, 6162 BG

  • Sanofi-Aventis Investigational Site Number 528002

    Sneek, 8601 ZK

  • Sanofi-Aventis Investigational Site Number 528035

    The Hague, 2545 CH

  • Sanofi-Aventis Investigational Site Number 528033

    Tilburg, 5022 GC

  • Sanofi-Aventis Investigational Site Number 528021

    Venlo, 5912 BL

  • Sanofi-Aventis Investigational Site Number 528005

    Zoetermeer, 2725 NA

  • Sanofi-Aventis Investigational Site Number 528025

    Zwolle, 8011 JW

Other trials in Netherlands

India17 sites

  • Sanofi-Aventis Investigational Site Number 356001

    Ahmedabad, 380 015

  • Sanofi-Aventis Investigational Site Number 356010

    Ahmedabad, 380054

  • Sanofi-Aventis Investigational Site Number 356015

    Bangalore, 560034

  • Sanofi-Aventis Investigational Site Number 356009

    Bangalore, 562 150

  • Sanofi-Aventis Investigational Site Number 356005

    Chennai, 600 037

  • Sanofi-Aventis Investigational Site Number 356002

    Coimbatore, 641004

  • Sanofi-Aventis Investigational Site Number 356007

    Coimbatore, 641014

  • Sanofi-Aventis Investigational Site Number 356013

    Lucknow, 226003

  • Sanofi-Aventis Investigational Site Number 356006

    Lucknow, 226014

  • Sanofi-Aventis Investigational Site Number 356017

    Mumbai, 54

  • Sanofi-Aventis Investigational Site Number 356014

    Mysore, 570020

  • Sanofi-Aventis Investigational Site Number 356020

    Nashik, 42003

  • Sanofi-Aventis Investigational Site Number 356004

    New Delhi, 110060

  • Sanofi-Aventis Investigational Site Number 356012

    New Delhi

  • Sanofi-Aventis Investigational Site Number 356018

    Pune, 400011

  • Sanofi-Aventis Investigational Site Number 356011

    Pune, 411004

  • Sanofi-Aventis Investigational Site Number 356003

    Secunderabad, 500 003

Other trials in India

Italy16 sites

  • Sanofi-Aventis Investigational Site Number 380015

    Ascoli Piceno, 63100

  • Sanofi-Aventis Investigational Site Number 380018

    Borgo San Lorenzo, 50032

  • Sanofi-Aventis Investigational Site Number 380016

    Chieti, 66013

  • Sanofi-Aventis Investigational Site Number 380005

    Fidenza, 43036

  • Sanofi-Aventis Investigational Site Number 380010

    Merate, 23807

  • Sanofi-Aventis Investigational Site Number 380014

    Milan, 20132

  • Sanofi-Aventis Investigational Site Number 380020

    Novara, 28100

  • Sanofi-Aventis Investigational Site Number 380001

    Padova, 35128

  • Sanofi-Aventis Investigational Site Number 380007

    Padova, 35128

  • Sanofi-Aventis Investigational Site Number 380004

    Palermo, 90127

  • Sanofi-Aventis Investigational Site Number 380008

    Pavia, 27100

  • Sanofi-Aventis Investigational Site Number 380021

    Perugia, 06132

  • Sanofi-Aventis Investigational Site Number 380013

    San Daniele del Friuli, 33038

  • Sanofi-Aventis Investigational Site Number 380003

    Sassari, 07100

  • Sanofi-Aventis Investigational Site Number 380011

    Torino, 10144

  • Sanofi-Aventis Investigational Site Number 380009

    Treviso, 31100

Other trials in Italy

Brazil15 sites

  • Sanofi-Aventis Investigational Site Number 076019

    Belo Horizonte, 30150-221

  • Sanofi-Aventis Investigational Site Number 076011

    Campina Grande do Sul, 83430-000

  • Sanofi-Aventis Investigational Site Number 076007

    Campinas, 13059-740

  • Sanofi-Aventis Investigational Site Number 076013

    Campinas, 13083-190

  • Sanofi-Aventis Investigational Site Number 076001

    Curitiba, 80730-150

  • Sanofi-Aventis Investigational Site Number 076017

    Goiânia, 74223-130

  • Sanofi-Aventis Investigational Site Number 076016

    Goiânia, 74605-020

  • Sanofi-Aventis Investigational Site Number 076018

    Maceió, 57021-500

  • Sanofi-Aventis Investigational Site Number 076012

    Porto Alegre, 90610-000

  • Sanofi-Aventis Investigational Site Number 076008

    Porto Alegre, 90810-120

  • Sanofi-Aventis Investigational Site Number 076014

    Porto Alegre, 91350 200

  • Sanofi-Aventis Investigational Site Number 076009

    Recife, 52051-380

  • Sanofi-Aventis Investigational Site Number 076005

    São José do Rio Preto, 15015-210

  • Sanofi-Aventis Investigational Site Number 076010

    São Paulo, 04024-002

  • Sanofi-Aventis Investigational Site Number 076015

    Uberlândia, 38400 299

Other trials in Brazil

South Africa14 sites

  • Sanofi-Aventis Investigational Site Number 710011

    Bloemfontein

  • Sanofi-Aventis Investigational Site Number 710007

    Cape Town, 7129

  • Sanofi-Aventis Investigational Site Number 710017

    Cape Town, 7764

  • Sanofi-Aventis Investigational Site Number 710001

    Durban, 4092

  • Sanofi-Aventis Investigational Site Number 710012

    Durban

  • Sanofi-Aventis Investigational Site Number 710013

    eManzimtoti

  • Sanofi-Aventis Investigational Site Number 710009

    Johannesburg, 1449

  • Sanofi-Aventis Investigational Site Number 710016

    Port Elizabeth

  • Sanofi-Aventis Investigational Site Number 710020

    Pretoria, 0050

  • Sanofi-Aventis Investigational Site Number 710003

    Pretoria, 0084

  • Sanofi-Aventis Investigational Site Number 710002

    Pretoria, 0204

  • Sanofi-Aventis Investigational Site Number 710015

    Randburg, 2194

  • Sanofi-Aventis Investigational Site Number 710014

    Scottburgh

  • Sanofi-Aventis Investigational Site Number 710018

    Umhlanga, 4400

Other trials in South Africa

Ukraine14 sites

  • Sanofi-Aventis Investigational Site Number 804013

    Dnipro

  • Sanofi-Aventis Investigational Site Number 804015

    Dnipro

  • Sanofi-Aventis Investigational Site Number 804005

    Dnipropetrovsk

  • Sanofi-Aventis Investigational Site Number 804008

    Ivano-Frankivsk

  • Sanofi-Aventis Investigational Site Number 804002

    Kharkiv

  • Sanofi-Aventis Investigational Site Number 804004

    Kharkiv

  • Sanofi-Aventis Investigational Site Number 804012

    Kharkiv

  • Sanofi-Aventis Investigational Site Number 804003

    Kiev

  • Sanofi-Aventis Investigational Site Number 804007

    Lutsk

  • Sanofi-Aventis Investigational Site Number 804009

    Lutsk

  • Sanofi-Aventis Investigational Site Number 804011

    Odesa

  • Sanofi-Aventis Investigational Site Number 804010

    Ternopil

  • Sanofi-Aventis Investigational Site Number 804006

    Uzhhorod

  • Sanofi-Aventis Investigational Site Number 804014

    Zaporizhzhya

Other trials in Ukraine

Poland13 sites

  • Sanofi-Aventis Investigational Site Number 616013

    Chojnice, 89-600

  • Sanofi-Aventis Investigational Site Number 616011

    Gdansk, 81-756

  • Sanofi-Aventis Investigational Site Number 616014

    Gdynia-Redlowo, 81-402

  • Sanofi-Aventis Investigational Site Number 616009

    Katowice, 40-635

  • Sanofi-Aventis Investigational Site Number 616017

    Lodz, 91-425

  • Sanofi-Aventis Investigational Site Number 616002

    Lublin, 20-954

  • Sanofi-Aventis Investigational Site Number 616012

    Ostrowiec Świętokrzyski, 27-400

  • Sanofi-Aventis Investigational Site Number 616015

    Puławy, 24-100

  • Sanofi-Aventis Investigational Site Number 616007

    Torun, 87-100

  • Sanofi-Aventis Investigational Site Number 616006

    Tychy, 43-100

  • Sanofi-Aventis Investigational Site Number 616001

    Warsaw, 02-005

  • Sanofi-Aventis Investigational Site Number 616010

    Warsaw, 02-097

  • Sanofi-Aventis Investigational Site Number 616008

    Wroclaw, 50-349

Other trials in Poland

Argentina10 sites

  • Sanofi-Aventis Investigational Site Number 032007

    Buenos Aires, 1221

  • Sanofi-Aventis Investigational Site Number 032011

    Buenos Aires, 1416

  • Sanofi-Aventis Investigational Site Number 032001

    Buenos Aires, C1428AQK

  • Sanofi-Aventis Investigational Site Number 032005

    Buenos Aires, C1437JCP

  • Sanofi-Aventis Investigational Site Number 032009

    Capital Federal, C1094AAD

  • Sanofi-Aventis Investigational Site Number 032012

    Corrientes, 3400

  • Sanofi-Aventis Investigational Site Number 032006

    Mar del Plata, 7600

  • Sanofi-Aventis Investigational Site Number 032014

    Morón

  • Sanofi-Aventis Investigational Site Number 032016

    Salta, 4400

  • Sanofi-Aventis Investigational Site Number 032010

    Zárate, 2800

Other trials in Argentina

Czechia10 sites

  • Sanofi-Aventis Investigational Site Number 203005

    Chomutov, 43012

  • Sanofi-Aventis Investigational Site Number 203003

    Jihlava, 58633

  • Sanofi-Aventis Investigational Site Number 203009

    Ostrava Vitkovice, 70300

  • Sanofi-Aventis Investigational Site Number 203001

    Pardubice, 53203

  • Sanofi-Aventis Investigational Site Number 203011

    Plzen - Bory, 30599

  • Sanofi-Aventis Investigational Site Number 203002

    Prague, 12808

  • Sanofi-Aventis Investigational Site Number 203004

    Prague, 14059

  • Sanofi-Aventis Investigational Site Number 203010

    Prague, 16902

  • Sanofi-Aventis Investigational Site Number 203006

    Prostějov, 796 04

  • Sanofi-Aventis Investigational Site Number 203008

    Ústí nad Orlicí, 56218

Other trials in Czechia

Israel10 sites

  • Sanofi-Aventis Investigational Site Number 376003

    Afula, 18101

  • Sanofi-Aventis Investigational Site Number 376015

    Ashkelon, 78278

  • Sanofi-Aventis Investigational Site Number 376001

    Giv‘atayim, 53583

  • Sanofi-Aventis Investigational Site Number 376007

    Haifa, 31048

  • Sanofi-Aventis Investigational Site Number 376014

    Haifa, 31096

  • Sanofi-Aventis Investigational Site Number 376004

    Holon, 58100

  • Sanofi-Aventis Investigational Site Number 376012

    Nahariya, 22100

  • Sanofi-Aventis Investigational Site Number 376009

    Nazareth, 16100

  • Sanofi-Aventis Investigational Site Number 376011

    Rehovot, 76100

  • Sanofi-Aventis Investigational Site Number 376002

    Tel Aviv, 64239

Other trials in Israel

Mexico10 sites

  • Sanofi-Aventis Investigational Site Number 484008

    Acapulco, 39670

  • Sanofi-Aventis Investigational Site Number 484013

    Aguascalientes, 20230

  • Sanofi-Aventis Investigational Site Number 484016

    Aguascalientes, 20230

  • Sanofi-Aventis Investigational Site Number 484004

    Guadalajara, 4428

  • Sanofi-Aventis Investigational Site Number 484007

    Guadalajara, 44340

  • Sanofi-Aventis Investigational Site Number 484012

    Mexico City, 07300

  • Sanofi-Aventis Investigational Site Number 484010

    Monterrey, 64060

  • Sanofi-Aventis Investigational Site Number 484011

    San Luis Potosí City, 72244

  • Sanofi-Aventis Investigational Site Number 484005

    San Luis Potosí City, 78200

  • Sanofi-Aventis Investigational Site Number 484003

    Veracruz, 91700

Other trials in Mexico

South Korea10 sites

  • Sanofi-Aventis Investigational Site Number 410008

    Anyang, 431-070

  • Sanofi-Aventis Investigational Site Number 410002

    Daegu, 700-712

  • Sanofi-Aventis Investigational Site Number 410006

    Goyang, 411-706

  • Sanofi-Aventis Investigational Site Number 410012

    Goyang, 411-773

  • Sanofi-Aventis Investigational Site Number 410007

    Gwangju, 501-757

  • Sanofi-Aventis Investigational Site Number 410003

    Seongnam, 463-802

  • Sanofi-Aventis Investigational Site Number 410001

    Seoul, 134-701

  • Sanofi-Aventis Investigational Site Number 410004

    Seoul, 135-710

  • Sanofi-Aventis Investigational Site Number 410005

    Seoul, 138-736

  • Sanofi-Aventis Investigational Site Number 410011

    Seoul, 140-210

Other trials in South Korea

Australia8 sites

  • Sanofi-Aventis Investigational Site Number 036006

    Adelaide, 5035

  • Sanofi-Aventis Investigational Site Number 036003

    Auchenflower, 4066

  • Sanofi-Aventis Investigational Site Number 036008

    Box Hill, 3128

  • Sanofi-Aventis Investigational Site Number 036005

    Coffs Harbour, 2450

  • Sanofi-Aventis Investigational Site Number 036001

    Kippa-Ring, 4021

  • Sanofi-Aventis Investigational Site Number 036002

    Kippa-Ring, 4021

  • Sanofi-Aventis Investigational Site Number 036009

    Launceston, 7250

  • Sanofi-Aventis Investigational Site Number 036010

    Woden, 2606

Other trials in Australia

Chile8 sites

  • Sanofi-Aventis Investigational Site Number 152007

    Santiago, 750-0691

  • Sanofi-Aventis Investigational Site Number 152001

    Santiago, 8053095

  • Sanofi-Aventis Investigational Site Number 152003

    Santiago

  • Sanofi-Aventis Investigational Site Number 152004

    Santiago

  • Sanofi-Aventis Investigational Site Number 152005

    Santiago

  • Sanofi-Aventis Investigational Site Number 152008

    Santiago

  • Sanofi-Aventis Investigational Site Number 152009

    Viña del Mar, 257-0017

  • Sanofi-Aventis Investigational Site Number 152006

    Viña del Mar

Other trials in Chile

Denmark7 sites

  • Sanofi-Aventis Investigational Site Number 208002

    Glostrup Municipality, 2600

  • Sanofi-Aventis Investigational Site Number 208001

    Hellerup, 2900

  • Sanofi-Aventis Investigational Site Number 208007

    Hvidovre, 2650

  • Sanofi-Aventis Investigational Site Number 208003

    København S, 2300

  • Sanofi-Aventis Investigational Site Number 208004

    Odense, 5000

  • Sanofi-Aventis Investigational Site Number 208006

    Roskilde, 4000

  • Sanofi-Aventis Investigational Site Number 208005

    Svendborg, 5700

Other trials in Denmark

Greece7 sites

  • Sanofi-Aventis Investigational Site Number 300009

    Athens, 11521

  • Sanofi-Aventis Investigational Site Number 300007

    Athens, 11527

  • Sanofi-Aventis Investigational Site Number 300002

    Athens, 11538

  • Sanofi-Aventis Investigational Site Number 300005

    Athens

  • Sanofi-Aventis Investigational Site Number 300006

    Chalcis, 34 100

  • Sanofi-Aventis Investigational Site Number 300004

    Chios

  • Sanofi-Aventis Investigational Site Number 300008

    Elefsina, 19600

Other trials in Greece

Turkey (Türkiye)7 sites

  • Sanofi-Aventis Investigational Site Number 792004

    Edirne

  • Sanofi-Aventis Investigational Site Number 792005

    Edirne

  • Sanofi-Aventis Investigational Site Number 792002

    Istanbul, 34034

  • Sanofi-Aventis Investigational Site Number 792001

    Istanbul

  • Sanofi-Aventis Investigational Site Number 792003

    Istanbul

  • Sanofi-Aventis Investigational Site Number 792006

    Kocaeli, 41300

  • Sanofi-Aventis Investigational Site Number 792007

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Sweden6 sites

  • Sanofi-Aventis Investigational Site Number 752003

    Gothenburg, 413 45

  • Sanofi-Aventis Investigational Site Number 752006

    Gothenburg, 413 45

  • Sanofi-Aventis Investigational Site Number 752002

    Malmö, 20502

  • Sanofi-Aventis Investigational Site Number 752007

    Malmö, 211 52

  • Sanofi-Aventis Investigational Site Number 752004

    Östersund, 831 83

  • Sanofi-Aventis Investigational Site Number 752001

    Stockholm, SE-171 76

Other trials in Sweden

Bulgaria5 sites

  • Sanofi-Aventis Investigational Site Number 100004

    Pleven, 5800

  • Sanofi-Aventis Investigational Site Number 100005

    Plovdiv, 4003

  • Sanofi-Aventis Investigational Site Number 100001

    Sofia, 1309

  • Sanofi-Aventis Investigational Site Number 100002

    Sofia, 1606

  • Sanofi-Aventis Investigational Site Number 100003

    Sofia, 1618

Other trials in Bulgaria

Colombia5 sites

  • Sanofi-Aventis Investigational Site Number 170003

    Bogotá

  • Sanofi-Aventis Investigational Site Number 170006

    Bogotá

  • Sanofi-Aventis Investigational Site Number 170001

    Bucaramanga

  • Sanofi-Aventis Investigational Site Number 170005

    Envigado-Antioquia

  • Sanofi-Aventis Investigational Site Number 170002

    Medellín

Other trials in Colombia

Peru5 sites

  • Sanofi-Aventis Investigational Site Number 604004

    Lima, CALLAO 2

  • Sanofi-Aventis Investigational Site Number 604002

    Lima, Lima 11

  • Sanofi-Aventis Investigational Site Number 604001

    Lima, LIMA 13

  • Sanofi-Aventis Investigational Site Number 604005

    Lima, LIMA 31

  • Sanofi-Aventis Investigational Site Number 604003

    Lima, LIMA 41

Other trials in Peru

Slovakia5 sites

  • Sanofi-Aventis Investigational Site Number 703003

    Košice, 04015

  • Sanofi-Aventis Investigational Site Number 703005

    Levice

  • Sanofi-Aventis Investigational Site Number 703004

    Nitra, 950 01

  • Sanofi-Aventis Investigational Site Number 703006

    Poprad, 05845

  • Sanofi-Aventis Investigational Site Number 703002

    Trnava, 91775

Other trials in Slovakia

Spain5 sites

  • Sanofi-Aventis Investigational Site Number 724003

    Barcelona, 08003

  • Sanofi-Aventis Investigational Site Number 724002

    Barcelona, 08036

  • Sanofi-Aventis Investigational Site Number 724001

    Madrid, 28046

  • Sanofi-Aventis Investigational Site Number 724005

    Santiago de Compostela, 15706

  • Sanofi-Aventis Investigational Site Number 724007

    Seville, 41006

Other trials in Spain

Taiwan5 sites

  • Sanofi-Aventis Investigational Site Number 158003

    Kaohsiung City, 833

  • Sanofi-Aventis Investigational Site Number 158002

    Taichung

  • Sanofi-Aventis Investigational Site Number 158004

    Tainan Hsien, 710

  • Sanofi-Aventis Investigational Site Number 158001

    Taipei

  • Sanofi-Aventis Investigational Site Number 158005

    Taipei

Other trials in Taiwan

Belarus4 sites

  • Sanofi-Aventis Investigational Site Number 112001

    Minsk, 220013

  • Sanofi-Aventis Investigational Site Number 112002

    Minsk, 220116

  • Sanofi-Aventis Investigational Site Number 112003

    Minsk, 220116

  • Sanofi-Aventis Investigational Site Number 112005

    Minsk, 220600

Other trials in Belarus

Canada4 sites

  • Sanofi-Aventis Investigational Site Number 124014

    London, N6A 5A5

  • Sanofi-Aventis Investigational Site Number 124006

    Newmarket, L3Y 8C3

  • Sanofi-Aventis Investigational Site Number 124012

    Québec, G1V 4G5

  • Sanofi-Aventis Investigational Site Number 124011

    Toronto, M5G 2C4

Other trials in Canada

Egypt4 sites

  • Sanofi-Aventis Investigational Site Number 818002

    Alexandria

  • Sanofi-Aventis Investigational Site Number 818003

    Alexandria

  • Sanofi-Aventis Investigational Site Number 818004

    Alexandria

  • Sanofi-Aventis Investigational Site Number 818001

    Cairo

Other trials in Egypt

Estonia4 sites

  • Sanofi-Aventis Investigational Site Number 233003

    Tallinn, 10138

  • Sanofi-Aventis Investigational Site Number 233004

    Tallinn, 13415

  • Sanofi-Aventis Investigational Site Number 233001

    Tallinn, 13419

  • Sanofi-Aventis Investigational Site Number 233002

    Tartu, 50410

Other trials in Estonia

Guatemala4 sites

  • Sanofi-Aventis Investigational Site Number 320002

    Guatemala City, 01010

  • Sanofi-Aventis Investigational Site Number 320001

    Guatemala City, 01014

  • Sanofi-Aventis Investigational Site Number 320003

    Guatemala City, 01014

  • Sanofi-Aventis Investigational Site Number 320004

    Guatemala City

Other trials in Guatemala

Lithuania4 sites

  • Sanofi-Aventis Investigational Site Number 440004

    Kaunas, 3007

  • Sanofi-Aventis Investigational Site Number 440002

    Kaunas, LT-49456

  • Sanofi-Aventis Investigational Site Number 440003

    Vilnius, LT-07156

  • Sanofi-Aventis Investigational Site Number 440001

    Vilnius, LT-08661

Other trials in Lithuania

Norway4 sites

  • Sanofi-Aventis Investigational Site Number 578001

    Bergen, 5021

  • Sanofi-Aventis Investigational Site Number 578006

    Flekkefjord, 4400

  • Sanofi-Aventis Investigational Site Number 578005

    Lørenskog, 1478

  • Sanofi-Aventis Investigational Site Number 578004

    Oslo, 0027

Other trials in Norway

Portugal4 sites

  • Sanofi-Aventis Investigational Site Number 620002

    Amadora, 2720-276

  • Sanofi-Aventis Investigational Site Number 620007

    Braga, 4701-968

  • Sanofi-Aventis Investigational Site Number 620006

    Coimbra, 3000-075

  • Sanofi-Aventis Investigational Site Number 620008

    Setúbal, 2910-446

Other trials in Portugal

Croatia3 sites

  • Sanofi-Aventis Investigational Site Number 191003

    Split, 21000

  • Sanofi-Aventis Investigational Site Number 191001

    Zagreb, 10000

  • Sanofi-Aventis Investigational Site Number 191004

    Zagreb, 10000

Other trials in Croatia

Malaysia3 sites

  • Sanofi-Aventis Investigational Site Number 458002

    George Town, 10450

  • Sanofi-Aventis Investigational Site Number 458001

    Kuching, 93586

  • Sanofi-Aventis Investigational Site Number 458005

    Taiping, 34000

Other trials in Malaysia

New Zealand3 sites

  • Sanofi-Aventis Investigational Site Number 554003

    Christchurch

  • Sanofi-Aventis Investigational Site Number 554002

    Dunedin

  • Sanofi-Aventis Investigational Site Number 554001

    Nelson

Other trials in New Zealand

Panama3 sites

  • Sanofi-Aventis Investigational Site Number 591001

    Panama City

  • Sanofi-Aventis Investigational Site Number 591002

    Panama City

  • Sanofi-Aventis Investigational Site Number 591003

    Panama City

Other trials in Panama

Thailand3 sites

  • Sanofi-Aventis Investigational Site Number 764001

    Bangkok, 10330

  • Sanofi-Aventis Investigational Site Number 764002

    Bangkok Noi, 10700

  • Sanofi-Aventis Investigational Site Number 764003

    Muang, 50200

Other trials in Thailand

Austria2 sites

  • Sanofi-Aventis Investigational Site Number 040001

    Graz, 8036

  • Sanofi-Aventis Investigational Site Number 040004

    Linz, 4021

Other trials in Austria

Indonesia2 sites

  • Sanofi-Aventis Investigational Site Number 360002

    Jakarta, 10430

  • Sanofi-Aventis Investigational Site Number 360001

    Jakarta

Other trials in Indonesia

Morocco2 sites

  • Sanofi-Aventis Investigational Site Number 504001

    Marrakesh, 40000

  • Sanofi-Aventis Investigational Site Number 504002

    Meknes, 50000

Other trials in Morocco

Venezuela2 sites

  • Sanofi-Aventis Investigational Site Number 862001

    Caracas

  • Sanofi-Aventis Investigational Site Number 862002

    Maracay, 2103

Other trials in Venezuela

Costa Rica1 site

  • Sanofi-Aventis Investigational Site Number 188004

    San José

Other trials in Costa Rica

Finland1 site

  • Sanofi-Aventis Investigational Site Number 246001

    Helsinki, 00290

Other trials in Finland

Philippines1 site

  • Sanofi-Aventis Investigational Site Number 608001

    Quezon City, 1102

Other trials in Philippines

Puerto Rico1 site

  • Sanofi-Aventis Investigational Site Number 630001

    San Juan, 00921-3201

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

Read the detailed description

The end of the study is defined by a common study end date for all participants, defined as 9 months (39 weeks) after the last participant randomized.

All participants will receive oral warfarin (or matching placebo) and weekly SC injections of idrabiotaparinux sodium (or matching placebo) up to 6 months before the common study end date. All participants are expected to be treated for at least 6 months.

All participants will have then an 6-month observational period after cessation of study treatment.

Being tested
Idrabiotaparinux sodium, Warfarin, Placebo (for idrabiotaparinux), Placebo (for warfarin), Avidin
Keywords
stroke, systemic thromboembolic events
Medical subject headings
Atrial Fibrillation, Stroke

What participants receive

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

  • Idrabiotaparinux sodiumDrug

    Also called SSR126517, Biotinylated idraparinux

    Pre-filled syringes containing:

    • 0.5 mL for the 3.0 mg dosage;
    • 0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old);
    • 0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years).

    Subcutaneous injection

  • WarfarinDrug

    Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)

    Oral administration

  • Placebo (for idrabiotaparinux)Drug

    Matching pre-filled syringes containing:

    • 0.5 mL for the 3.0 mg dosage;
    • 0.33 mL for the 2.0 mg dosage (maintenance dosage for participants with mild renal impairment and less than 75 years old);
    • 0.25 mL for the 1.5 mg dosage (maintenance dosage for participants with moderate renal impairment or age ≥75 years).

    Subcutaneous injection

  • Placebo (for warfarin)Drug

    Warfarin matching capsules

    Oral administration

  • AvidinDrug

    Also called SSR29261

    Vial containing 105 mg of lyophilized powder for dilution

    Intravenous infusion for 30 minutes

  • Placebo (for avidin)Drug

    Vial containing 105 mg of matching lyophilized powder for dissolution

    Intravenous infusion for 30 minutes

Study groups in NCT00580216
Study groupRoleWhat they receive
IdrabiotaparinuxExperimentalIdrabiotaparinux sodium, 3.0 mg, once-weekly for 7 weeks followed a maintenance dosing adjusted according to the age and to the renal function for a minimum total treatment duration of 6 months. Avidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or overdosage).
Receives: Drug: Idrabiotaparinux sodium; Drug: Placebo (for warfarin); Drug: Avidin
WarfarinActive comparatorWarfarin, INR-adjusted dose, for a minimum total treatment duration of 6 months.
Receives: Drug: Warfarin; Drug: Placebo (for idrabiotaparinux); Drug: Placebo (for avidin)

What is being measured

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

  1. Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE)

    Measured: From randomization up to the end of the treatment period (minimum of 6 months)

Secondary outcomes (2)

  1. Components of the primary study outcome measure:

    Measured: From randomization up to the end of the treatment period (minimum of 6 months)

  2. Composite of stroke or non CNS SE or myocardial infarction (MI) or venous thromboembolism (VTE) or major bleeding or death

    Measured: From randomization up to the end of the treatment period (minimum of 6 months)

Timeline

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

  1. First posted24 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionOct 2010
  4. Study completionOct 2010

Why it stopped: early discontinuation based on strategic sponsor decision not driven by any safety concern

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,773 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00580216
Sponsor's protocol ID
EFC10295
Other IDs
2007-004817-33
Acronym
BOREALIS-AF
Status last verified
Feb 2016
First submitted
21 Dec 2007
Last updated
21 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Buller HR, Halperin J, Hankey GJ, Pillion G, Prins MH, Raskob GE. Comparison of idrabiotaparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: the Borealis-Atrial Fibrillation Study. J Thromb Haemost. 2014 Jun;12(6):824-30. doi: 10.1111/jth.12546.

    PubMed 24597472

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Idrabiotaparinux sodium, Warfarin and Avidin in people with Atrial Fibrillation, run by Sanofi at 538 sites in 48 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 11 inclusion and 0 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: stopped early, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 538 sites in United States, Russia, France, Netherlands, India and 43 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was stopped early (reason given: early discontinuation based on strategic sponsor decision not driven by any safety concern). Results are not available in the source record.

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?

Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) (time frame: From randomization up to the end of the treatment period (minimum of 6 months)). 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 NCT00580216, which also lists 1 linked publication.

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 21 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in