AzTrials
AzTrials

Prostatic HyperplasiaPhase 3NCT00090103

Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

A Phase 3 study testing dutasteride 0.5mg once daily for 4 years and tamsulosin 0.4mg once daily for 4 years in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 503 sites in 37 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

This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Prostatic Hyperplasia
What is being tested?
dutasteride 0.5mg once daily for 4 years and tamsulosin 0.4mg once daily for 4 years
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,844 participants
Where
503 sitesin 37 countries
Study dates
Nov 2003to Apr 2009
Phase
Phase 3
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
  • males, aged ≥50 years
  • clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
  • International Prostate Symptom Score (IPSS) ≥12 points at Screening
  • prostate volume ≥30 cc by transrectal ultrasonography; (TRUS)
  • total serum Prostate Specific Antigen (PSA) ≥1.5ng/mL at Screening
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  • maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids)
  • willing and able to give written informed consent and comply with study procedures
  • fluent and literate in local language with the ability to read, comprehend and record information on the IPSS, BII and Patient Perception of Study Medication
  • able to swallow and retain oral medication
  • willing and able to participate in the study for the full 4 years.

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • total serum PSA >10.0ng/mL at Screening
  • history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.
  • Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice.
  • previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH.
  • history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Routine catheterisation is acceptable with no time restriction.
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  • history of AUR within 3 months prior to Screening Visit.
  • post-void residual volume >250mL (suprapubic ultrasound) at Screening.
  • any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
  • history of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
  • use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®, Avodart®), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit and throughout the study (other than as study medication).
  • concurrent use of anabolic steroids
  • use of phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study.
  • use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of Screening Visit and/or predicted to need any alpha blockers other than tamsulosin during the study.
  • Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study.
  • use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments.
  • hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs.
  • concurrent use of drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
  • history of hepatic impairment or abnormal liver function tests at Screening defined as alanine aminotransferase (ALT), aspartate aminotranferase (AST), and/or alkaline phosphatase >2 times the upper limit of normal, or total bilirubin >1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome).
  • history of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal or serum creatinine ≥1.5 mg/dL at Screening.
  • prior history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible.
  • history of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
  • any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
  • history of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
  • history of unsuccessful treatment with tamsulosin or 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.
  • history of unsuccessful treatment with finasteride or dutasteride
  • history or current evidence of drug or alcohol abuse within the previous 12 months.
  • participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding the Screening Visit and/or during the course of this study.

Trial locations and contacts

503 sites in 37 countries.

503 sites in 37 countries

United States113 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Alexandria, Virginia, 22304

  • GSK Investigational Site

    Anchorage, Alaska, 99508

  • GSK Investigational Site

    Asheboro, North Carolina, 27203

  • GSK Investigational Site

    Athes, Texas, 75751

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Bay Pines, Florida, 33744

  • GSK Investigational Site

    Bay Shore, New York, 11706

  • GSK Investigational Site

    Bellbrook, Ohio, 45305

  • GSK Investigational Site

    Belleville, Illinois, 62220

  • GSK Investigational Site

    Bellevue, Washington, 98004

  • GSK Investigational Site

    Beverly Hills, California, 90212

  • GSK Investigational Site

    Birmingham, Alabama, 35209

  • GSK Investigational Site

    Birmingham, Alabama, 35234

  • GSK Investigational Site

    Birmingham, Alabama, 35242

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Bismarck, North Dakota, 58501

  • GSK Investigational Site

    Blue Ridge, Georgia, 30513

  • GSK Investigational Site

    Bossier City, Louisiana, 71111

  • GSK Investigational Site

    Calhoun, Georgia, 30701

  • GSK Investigational Site

    Cary, North Carolina, 27511

  • GSK Investigational Site

    Charlotte, North Carolina, 28262

  • GSK Investigational Site

    Cincinnati, Ohio, 45249

  • GSK Investigational Site

    Columbiana, Alabama, 35051

  • GSK Investigational Site

    Columbus, Ohio, 43212

  • GSK Investigational Site

    Columbus, Ohio, 43214

  • GSK Investigational Site

    Concord, California, 94520

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75234

  • GSK Investigational Site

    Dallas, Texas, 75390

  • GSK Investigational Site

    Daytona Beach, Florida, 32114

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Des Moines, Iowa, 50309

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fayetteville, North Carolina, 28304

  • GSK Investigational Site

    Fleetwood, Pennsylvania, 19522

  • GSK Investigational Site

    Fort Worth, Texas, 76107

  • GSK Investigational Site

    Garden City, New York, 11530

  • GSK Investigational Site

    Glendora, California, 91741

  • GSK Investigational Site

    Great Neck, New York, 11021

  • GSK Investigational Site

    Greenbrae, California, 94904

  • GSK Investigational Site

    Greensboro, North Carolina, 27403

  • GSK Investigational Site

    Henderson, Nevada, 89014

  • GSK Investigational Site

    Hillsborough, New Jersey, 08844

  • GSK Investigational Site

    Hoover, Alabama, 35216

  • GSK Investigational Site

    Houston, Texas, 77024

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Irvine, California, 92618

  • GSK Investigational Site

    Jeffersonville, Indiana, 47130

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    La Jolla, California, 92093

  • GSK Investigational Site

    Laguna Woods, California, 92637

  • GSK Investigational Site

    Lake Worth, Florida, 33461

  • GSK Investigational Site

    Laurel, Maryland, 20724

  • GSK Investigational Site

    Lewiston, New York, 14092

  • GSK Investigational Site

    Los Angelas, California, 90017

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Los Angeles, California, 90057

  • GSK Investigational Site

    Marietta, Georgia, 30066

  • GSK Investigational Site

    Meridian, Idaho, 83642

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Minneapolis, Minnesota, 55417

  • GSK Investigational Site

    Missoula, Montana, 59802

  • GSK Investigational Site

    Modesto, California, 95350

  • GSK Investigational Site

    Mountlake Terrace, Washington, 98043

  • GSK Investigational Site

    Murray, Kentucky, 42071

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Brunfels, Texas, 78130

  • GSK Investigational Site

    New Smyrna Beach, Florida, 32168

  • GSK Investigational Site

    Newburgh, Indiana, 47630

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Omaha, Nebraska, 68102

  • GSK Investigational Site

    Orange City, Florida, 32763

  • GSK Investigational Site

    Pensacola, Florida, 32503

  • GSK Investigational Site

    Peoria, Illinois, 61602

  • GSK Investigational Site

    Peoria, Illinois, 61614

  • GSK Investigational Site

    Perth Amboy, New Jersey, 08861

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Phoenix, Arizona, Arizona, 86106

  • GSK Investigational Site

    Picayune, Mississippi, 39466

  • GSK Investigational Site

    Pinecrest, Florida, 33156

  • GSK Investigational Site

    Portland, Oregon, 97239

  • GSK Investigational Site

    Providence, Rhode Island, 02904

  • GSK Investigational Site

    Sacramento, California, 95821

  • GSK Investigational Site

    Saint Augustine, Florida, 32086

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    Salt Lake City, Utah, 84132

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 91405

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    San Diego, California, 92108

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Somerville, New Jersey, 08876

  • GSK Investigational Site

    South Bend, Indiana, 46601

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Spring Hill, Florida, 34609

  • GSK Investigational Site

    St. Petersburg, Florida, 33702

  • GSK Investigational Site

    St. Petersburg, Florida, 33710

  • GSK Investigational Site

    Stuart, Florida, 34996

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Temple, Texas, 76508

  • GSK Investigational Site

    Texarkana, Texas, 75503

  • GSK Investigational Site

    Torrance, California, 90506

  • GSK Investigational Site

    Vista, California, 92084

  • GSK Investigational Site

    Wellington, Florida, 33414

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    Wheaton, Illinois, 60187

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Winfield, Illinois, 60190

Other trials in United States

France62 sites

  • GSK Investigational Site

    Agny, 62217

  • GSK Investigational Site

    Angers, 49000

  • GSK Investigational Site

    Annecy, 74000

  • GSK Investigational Site

    Arras, 62000

  • GSK Investigational Site

    Athis-Mons, 91200

  • GSK Investigational Site

    Besançon, 25000

  • GSK Investigational Site

    Bouchemaine, 49080

  • GSK Investigational Site

    Broglie, 27270

  • GSK Investigational Site

    Bully-les-Mines, Hauts-de-France, 62160

  • GSK Investigational Site

    Castelneau Le Nez, 34170

  • GSK Investigational Site

    Chambéry, 73000

  • GSK Investigational Site

    Chilly-Mazarin, 91380

  • GSK Investigational Site

    Cournonterral, 34460

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Domarin, 38300

  • GSK Investigational Site

    Épinay-sur-Orge, 91360

  • GSK Investigational Site

    Évreux, 27000

  • GSK Investigational Site

    Évreux, 27025

  • GSK Investigational Site

    Gif-sur-Yvette, 91190

  • GSK Investigational Site

    Grenoble, 38100

  • GSK Investigational Site

    La Seyne-sur-Mer, 83500

  • GSK Investigational Site

    Lamarque, 33460

  • GSK Investigational Site

    Laval, 53000

  • GSK Investigational Site

    Le Brusc, 83140

  • GSK Investigational Site

    Le Kremlin-Bicêtre, 94275

  • GSK Investigational Site

    Les Mureaux, 78130

  • GSK Investigational Site

    Lesparre-Médoc, 33340

  • GSK Investigational Site

    Linas, 91310

  • GSK Investigational Site

    Longpont-sur-Orge, 91310

  • GSK Investigational Site

    Lyon, 69008

  • GSK Investigational Site

    Melun, 77007

  • GSK Investigational Site

    Meudon, 92190

  • GSK Investigational Site

    Meylan, 38240

  • GSK Investigational Site

    Mont-de-Marsan, 40000

  • GSK Investigational Site

    Montauban, 82017

  • GSK Investigational Site

    Montpelier, 34000

  • GSK Investigational Site

    Montpellier, 34000

  • GSK Investigational Site

    Montpellier, 34100

  • GSK Investigational Site

    Orléans, 45067

  • GSK Investigational Site

    Paris, 75019

  • GSK Investigational Site

    Pontonx Sur Adour, 40465

  • GSK Investigational Site

    Roanne, 42300

  • GSK Investigational Site

    Saint-Chamond, 42400

  • GSK Investigational Site

    Saint-Denis, 93200

  • GSK Investigational Site

    Saint-Egrève, 38120

  • GSK Investigational Site

    Saint-Galmier, 42330

  • GSK Investigational Site

    Saint-Georges-dOrques, 34680

  • GSK Investigational Site

    Saint-Germain-Lespinasse, 42640

  • GSK Investigational Site

    Saint-Sébastien-de-Morsent, 27180

  • GSK Investigational Site

    Sainte-Suzanne, 53270

  • GSK Investigational Site

    Sanary-sur-Mer, 83110

  • GSK Investigational Site

    Sarlat-la-Canéda, 24200

  • GSK Investigational Site

    Seysses, 31600

  • GSK Investigational Site

    Six-Fours-les-Plages, 83140

  • GSK Investigational Site

    Suresnes, 92151

  • GSK Investigational Site

    Toulon, 83200

  • GSK Investigational Site

    Tours, 37044

  • GSK Investigational Site

    Vaucresson, 92420

  • GSK Investigational Site

    Verneuil-sur-Seine, 78480

  • GSK Investigational Site

    Villejuif, 94804

  • GSK Investigational Site

    Villeneuve-lès-Maguelone, 34750

  • GSK Investigational Site

    Vourey, 38210

Other trials in France

Germany56 sites

  • GSK Investigational Site

    Aalen, Baden-Wurttemberg, 73430

  • GSK Investigational Site

    Aichach, Bavaria, 86551

  • GSK Investigational Site

    Alzenau, Hesse, 63755

  • GSK Investigational Site

    Amberg, Bavaria, 92224

  • GSK Investigational Site

    Apolda, Thuringia, 99510

  • GSK Investigational Site

    Augsburg, Bavaria, 86150

  • GSK Investigational Site

    Berlin, State of Berlin, 10627

  • GSK Investigational Site

    Berlin, State of Berlin, 10719

  • GSK Investigational Site

    Berlin, State of Berlin, 12167

  • GSK Investigational Site

    Berlin, State of Berlin, 12347

  • GSK Investigational Site

    Berlin, State of Berlin, 12681

  • GSK Investigational Site

    Berlin, State of Berlin, 13053

  • GSK Investigational Site

    Berlin, State of Berlin, 13055

  • GSK Investigational Site

    Berlin, State of Berlin, 13125

  • GSK Investigational Site

    Berlin, State of Berlin, 13439

  • GSK Investigational Site

    Berlin, State of Berlin, 14197

  • GSK Investigational Site

    Delmenhorst, Lower Saxony, 27753

  • GSK Investigational Site

    Dülmen, North Rhine-Westphalia, 48249

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60326

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Fulda, Hesse, 36037

  • GSK Investigational Site

    Giessen, Hesse, 35390

  • GSK Investigational Site

    Graefeling, Bavaria, 82166

  • GSK Investigational Site

    Grimmen, Mecklenburg-Vorpommern, 18507

  • GSK Investigational Site

    Hagenow, Brandenburg, 19230

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06114

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 20253

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22415

  • GSK Investigational Site

    Hettstedt, Saxony-Anhalt, 06333

  • GSK Investigational Site

    Hohenstein-Ernsttal, Saxony, 09337

  • GSK Investigational Site

    Holzminden, Lower Saxony, 37603

  • GSK Investigational Site

    Husum, Schleswig-Holstein, 25813

  • GSK Investigational Site

    Kassel, Hesse, 34123

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24103

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Koenigstein, Hesse, 61462

  • GSK Investigational Site

    Konstanz, Baden-Wurttemberg, 78464

  • GSK Investigational Site

    Lauchhammer, Brandenburg, 01979

  • GSK Investigational Site

    Leipzig, Saxony, 04105

  • GSK Investigational Site

    Leipzig, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04277

  • GSK Investigational Site

    Marburg, Hesse, 35039

  • GSK Investigational Site

    Merseburg, Saxony-Anhalt, 06217

  • GSK Investigational Site

    Mosbach, Baden-Wurttemberg, 74821

  • GSK Investigational Site

    Neu-Ulm, Bavaria, 89231

  • GSK Investigational Site

    Oldenburg, Lower Saxony, 26121

  • GSK Investigational Site

    Oranienburg, Brandenburg, 16515

  • GSK Investigational Site

    Osnabrück, Lower Saxony, 49074

  • GSK Investigational Site

    Parchim, Mecklenburg-Vorpommern, 19370

  • GSK Investigational Site

    Rottweil, Baden-Wurttemberg, 78628

  • GSK Investigational Site

    Schongau, Bavaria, 86956

  • GSK Investigational Site

    Schwalbach, Hesse, 65824

  • GSK Investigational Site

    Senftenberg, Brandenburg, 01968

  • GSK Investigational Site

    Stadtlohn, North Rhine-Westphalia, 48703

  • GSK Investigational Site

    Stockach, Baden-Wurttemberg, 78333

  • GSK Investigational Site

    Wertingen, Bavaria, 86637

Other trials in Germany

Spain40 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Alava, 01004

  • GSK Investigational Site

    Alcázar de San Juan (Ciudad Real), 13600

  • GSK Investigational Site

    Badajoz, 6080

  • GSK Investigational Site

    Barcelona, 08022

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08221

  • GSK Investigational Site

    Burgos, 09005

  • GSK Investigational Site

    Ciudad Real, 13005

  • GSK Investigational Site

    Donostia / San Sebastian, 20012

  • GSK Investigational Site

    Elche (Alicante), 03202

  • GSK Investigational Site

    Gijón, 33394

  • GSK Investigational Site

    Guadalajara, 19002

  • GSK Investigational Site

    Jerez de la Frontera, 11407

  • GSK Investigational Site

    Langreo (Oviedo), 33920

  • GSK Investigational Site

    Las Palmas, 35020

  • GSK Investigational Site

    Las Palmas de Gran Canaria, 35016

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28016

  • GSK Investigational Site

    Málaga, 29020

  • GSK Investigational Site

    Manacor (Palma de Mallorca)

  • GSK Investigational Site

    Marbella, 29600

  • GSK Investigational Site

    Mendaro, Guipuzcoa, 20850

  • GSK Investigational Site

    Mérida, 6800

  • GSK Investigational Site

    Murcia, 30008

  • GSK Investigational Site

    Palma de Mallorca, 07014

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    Pontevedra, 36071

  • GSK Investigational Site

    Sabadell (Barcelona), 08208

  • GSK Investigational Site

    San Sebastián, 20014

  • GSK Investigational Site

    Santa Cruz de Tenerife, 38010

  • GSK Investigational Site

    Santander, 38008

  • GSK Investigational Site

    Santander

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Tortosa, 43500

  • GSK Investigational Site

    Valencia, 46009

  • GSK Investigational Site

    Vigo (Pontevedra), 30211

  • GSK Investigational Site

    Vigo/Pontevedra, 36200

  • GSK Investigational Site

    Vitoria-Gasteiz, 01009

  • GSK Investigational Site

    Vizcaya, 48902

Other trials in Spain

Canada33 sites

  • GSK Investigational Site

    Barrie, Ontario, L4M 7G1

  • GSK Investigational Site

    Brantford, Ontario, N3R 4N3

  • GSK Investigational Site

    Courtice, Ontario, L1E 3C3

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 4T3

  • GSK Investigational Site

    Guelph, Ontario, N1H 5J1

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 3A7

  • GSK Investigational Site

    Hamilton, Ontario, L8N 4A6

  • GSK Investigational Site

    Kentville, Nova Scotia, B4N 4K9

  • GSK Investigational Site

    Kingston, Ontario, K7L 2V7

  • GSK Investigational Site

    London, Ontario, M6A 4G5

  • GSK Investigational Site

    London, Ontario, N6A 4V2

  • GSK Investigational Site

    Montreal, Quebec, H2X 1N8

  • GSK Investigational Site

    Montreal, Quebec, H3A 1A1

  • GSK Investigational Site

    Montreal, Quebec, H3S 1Z1

  • GSK Investigational Site

    North Bay, Ontario, P1B 7K8

  • GSK Investigational Site

    Oakville, Ontario, L6H 3P1

  • GSK Investigational Site

    Oshawa, Ontario, L1H 7K4

  • GSK Investigational Site

    Ottawa, Ontario, K1Y 4E9

  • GSK Investigational Site

    Saint John, New Brunswick, E2L 4L2

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • GSK Investigational Site

    Saint-Jérôme, Quebec, J7Z 5T3

  • GSK Investigational Site

    Scarborough Village, Ontario, M1P 2T7

  • GSK Investigational Site

    Scarborough Village, Ontario, M1S 4V5

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 4S8

  • GSK Investigational Site

    Surrey, British Columbia, V3V 1N1

  • GSK Investigational Site

    Toronto, Ontario, M2K 2W1

  • GSK Investigational Site

    Toronto, Ontario, M4C 5T2

  • GSK Investigational Site

    Toronto, Ontario, M5T 2S8

  • GSK Investigational Site

    Toronto, Ontario, M6A 3B5

  • GSK Investigational Site

    Toronto, Ontario, M6S 4W4

  • GSK Investigational Site

    Trois-Rivières, Quebec, G9A 3V7

  • GSK Investigational Site

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Italy21 sites

  • GSK Investigational Site

    Acireale (CT), Sicily, 95124

  • GSK Investigational Site

    Avellino, Campania, 83100

  • GSK Investigational Site

    Bagno A Ripoli (FI), Tuscany, 50126

  • GSK Investigational Site

    Cagliari, Sardinia, 09134

  • GSK Investigational Site

    Castellamare Di Stabia (NA), Campania, 80053

  • GSK Investigational Site

    Catanzaro, Calabria, 88100

  • GSK Investigational Site

    Florence, Tuscany, 50139

  • GSK Investigational Site

    Genoa, Liguria, 16128

  • GSK Investigational Site

    Ivrea (TO), Piedmont, 10015

  • GSK Investigational Site

    Lecco, Lombardy, 23100

  • GSK Investigational Site

    Milan, Lombardy, 20132

  • GSK Investigational Site

    Modena, Emilia-Romagna, 41100

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Novara, Piedmont, 28100

  • GSK Investigational Site

    Portogruaro (VE), Veneto, 30026

  • GSK Investigational Site

    Rome, Lazio, 00189

  • GSK Investigational Site

    San Felice A Cancello Caserta, Campania, 81027

  • GSK Investigational Site

    Siena, Tuscany, 53100

  • GSK Investigational Site

    Torre Del Greco (NA), Campania, 80059

  • GSK Investigational Site

    Turin, Piedmont, 10126

  • GSK Investigational Site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Netherlands20 sites

  • GSK Investigational Site

    Alkmaar, 1815 JD

  • GSK Investigational Site

    Amstelveen, 1186 AM

  • GSK Investigational Site

    Amsterdam, 1034 CS

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Arnhem, 6842 CV

  • GSK Investigational Site

    Doetinchem, 7009 BL

  • GSK Investigational Site

    Enschede, 7511JX

  • GSK Investigational Site

    Etten-Leur, 4872 LA

  • GSK Investigational Site

    Groningen, 9713 GZ

  • GSK Investigational Site

    Groningen, 9721 SW

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Hilversum, 1213 XZ

  • GSK Investigational Site

    Hoofddorp, 2134 TM

  • GSK Investigational Site

    Maastricht, 6229 HX

  • GSK Investigational Site

    The Hague, 2566 MJ

  • GSK Investigational Site

    Tilburg, 5022 GC

  • GSK Investigational Site

    Tilburg, 5042 AD

  • GSK Investigational Site

    Veldhoven, 5504 DB

  • GSK Investigational Site

    Winterswijk, 7101 BN

  • GSK Investigational Site

    Zwijndrecht, 3331 LZ

Other trials in Netherlands

United Kingdom11 sites

  • GSK Investigational Site

    Buckshaw Village, Chorley, Lancashire, PR7 7NA

  • GSK Investigational Site

    Chichester, Sussex West, PO19 4SE

  • GSK Investigational Site

    Clydebank, Glasgow, G81 2DR

  • GSK Investigational Site

    Dundee, DD1 9SY

  • GSK Investigational Site

    Edgbaston, Birmingham, B15 2SQ

  • GSK Investigational Site

    Edinburgh, Midlothian, EH4 2XU

  • GSK Investigational Site

    Manchester, M15 6SX

  • GSK Investigational Site

    Northwood, Middlesex, HA6 2RN

  • GSK Investigational Site

    Oxford, Oxfordshire, OX2 6PD

  • GSK Investigational Site

    Swansea, Glamorgan, SA4 4NU

  • GSK Investigational Site

    Waterloo, Liverpool, L22 0LG

Other trials in United Kingdom

Norway10 sites

  • GSK Investigational Site

    Ålesund, N-6026

  • GSK Investigational Site

    Bergen, 5094

  • GSK Investigational Site

    Bodø, N-8009

  • GSK Investigational Site

    Haugesund, 5507

  • GSK Investigational Site

    Moelv, N-2390

  • GSK Investigational Site

    Nøtterøy, 3128

  • GSK Investigational Site

    Oslo, 0257 OSLO

  • GSK Investigational Site

    Oslo, 0514

  • GSK Investigational Site

    Porsgrunn, N-3922

  • GSK Investigational Site

    Tønsberg, 3116

Other trials in Norway

Russia9 sites

  • GSK Investigational Site

    Moscow, 105229

  • GSK Investigational Site

    Moscow, 109472

  • GSK Investigational Site

    Moscow, 117 837

  • GSK Investigational Site

    Moscow, 125206

  • GSK Investigational Site

    Moscow, 125367

  • GSK Investigational Site

    Moscow

  • GSK Investigational Site

    Rostov-on-Don

  • GSK Investigational Site

    Saint Petersburg

  • GSK Investigational Site

    Smolensk

Other trials in Russia

Belgium8 sites

  • GSK Investigational Site

    Antwerp, 2020

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1090

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    La Louvière, 7100

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Roeselare, 8800

Other trials in Belgium

Greece7 sites

  • GSK Investigational Site

    Athens, 115 21

  • GSK Investigational Site

    Athens, 115 22

  • GSK Investigational Site

    Athens, 15126

  • GSK Investigational Site

    Athens, 154 52

  • GSK Investigational Site

    Pátrai, 265 00

  • GSK Investigational Site

    Polygyros, 63 100

  • GSK Investigational Site

    Thassaloniki, 564 34

Other trials in Greece

Slovakia7 sites

  • GSK Investigational Site

    Banská Bystrica, 975 17

  • GSK Investigational Site

    Bratislava, 813 69

  • GSK Investigational Site

    Bratislava, 833 05

  • GSK Investigational Site

    Košice, 041 66

  • GSK Investigational Site

    Martin, 036 59

  • GSK Investigational Site

    Skalica, 909 01

  • GSK Investigational Site

    Žilina, 010 01

Other trials in Slovakia

Taiwan7 sites

  • GSK Investigational Site

    Kaohsiung City, 813

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Tainan, 704

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 112

  • GSK Investigational Site

    Taipei, 114

  • GSK Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Argentina6 sites

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, 1120

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, 1416

  • GSK Investigational Site

    Buenos Aires, 1111

  • GSK Investigational Site

    Buenos Aires, 1405

  • GSK Investigational Site

    Buenos Aires, C1181ACI

  • GSK Investigational Site

    Ciudad de Buenos Aires, 1118

Other trials in Argentina

Brazil6 sites

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30130-008

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90470-340

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • GSK Investigational Site

    Rio de Janeiro, Rio de Janeiro, 20 551-030

  • GSK Investigational Site

    São Paulo, São Paulo, 04262-000

Other trials in Brazil

Czechia6 sites

  • GSK Investigational Site

    Hradec Králové, 536 00

  • GSK Investigational Site

    Ostrava - Poruba, 708 52

  • GSK Investigational Site

    Prague, 130 00

  • GSK Investigational Site

    Prague, 150 18

  • GSK Investigational Site

    Prague, 180 71

  • GSK Investigational Site

    Roudnice nad Labem, 413 01

Other trials in Czechia

Israel6 sites

  • GSK Investigational Site

    Haifa, 31048

  • GSK Investigational Site

    Haifa

  • GSK Investigational Site

    Holon, 58100

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Zrifin, 70300

Other trials in Israel

Mexico6 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44340

  • GSK Investigational Site

    México, 06700

  • GSK Investigational Site

    Mexico City, 06720

  • GSK Investigational Site

    Mexico City, 14050

  • GSK Investigational Site

    Zapopan, Jalisco, 45170

  • GSK Investigational Site

    Zapopan, Jalisco, Jalisco, 45100

Other trials in Mexico

Portugal6 sites

  • GSK Investigational Site

    Abrantes, 2200 Abrantes

  • GSK Investigational Site

    Lisbon, 1069-166

  • GSK Investigational Site

    Lisbon, 1269-098 Lisboa

  • GSK Investigational Site

    Porto, 4099-004

  • GSK Investigational Site

    Porto, 4150-113 PORTO

  • GSK Investigational Site

    S. Martinho Do Bispo, 3040-316 Coimbra

Other trials in Portugal

Romania6 sites

  • GSK Investigational Site

    Arad, 310175

  • GSK Investigational Site

    Bucharest, 022328

  • GSK Investigational Site

    Bucharest

  • GSK Investigational Site

    Cluj-Napoca

  • GSK Investigational Site

    Iași

  • GSK Investigational Site

    Timișoara

Other trials in Romania

Bulgaria5 sites

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Sofia, 1000

  • GSK Investigational Site

    Sofia, 1431/1000

  • GSK Investigational Site

    Sofia, 1606

  • GSK Investigational Site

    Varna, 9002

Other trials in Bulgaria

Finland5 sites

  • GSK Investigational Site

    Helsinki, 00150

  • GSK Investigational Site

    Jakobstad, 68600

  • GSK Investigational Site

    Kouvola, 45200

  • GSK Investigational Site

    Kuopio, 70100

  • GSK Investigational Site

    Tampere, 33520

Other trials in Finland

Lithuania5 sites

  • GSK Investigational Site

    Kaunas, LT-47144

  • GSK Investigational Site

    Kaunas, LT-49287

  • GSK Investigational Site

    Klaipėda, LT-92231

  • GSK Investigational Site

    Klaipėda, LT-92288

  • GSK Investigational Site

    Vilnius, LT-10207

Other trials in Lithuania

Poland5 sites

  • GSK Investigational Site

    Gdansk, 80-402

  • GSK Investigational Site

    Krakow, 31-221

  • GSK Investigational Site

    Krakow, 31-826

  • GSK Investigational Site

    Lublin, 20-950

  • GSK Investigational Site

    Wroclaw, 50-043

Other trials in Poland

South Korea5 sites

  • GSK Investigational Site

    Pusan, 602-739

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Seoul, 135-720

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Seoul, 150-015

Other trials in South Korea

Denmark4 sites

  • GSK Investigational Site

    Aalborg, 9100

  • GSK Investigational Site

    Aarhus N, 8200

  • GSK Investigational Site

    Fredericia, 7000

  • GSK Investigational Site

    Randers, 8900

Other trials in Denmark

Estonia4 sites

  • GSK Investigational Site

    Tallinn, 1162

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 51014

  • GSK Investigational Site

    Tartu

Other trials in Estonia

Hungary4 sites

  • GSK Investigational Site

    Budapest, 1036.

  • GSK Investigational Site

    Sopron, 9400

  • GSK Investigational Site

    Székesfehérvár, 8000

  • GSK Investigational Site

    Veszprém, 8200

Other trials in Hungary

South Africa4 sites

  • GSK Investigational Site

    Cape Town, 8001

  • GSK Investigational Site

    Claremont, 7700

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Sunninghill, 2157

Other trials in South Africa

Thailand4 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Bangkok, 10700

  • GSK Investigational Site

    Chiang Mai, 50200

Other trials in Thailand

Tunisia3 sites

  • GSK Investigational Site

    Sousse, 4054

  • GSK Investigational Site

    Tunis, 1007

  • GSK Investigational Site

    Tunis, 1008

Other trials in Tunisia

Turkey (Türkiye)3 sites

  • GSK Investigational Site

    Istanbul, 34303

  • GSK Investigational Site

    Izmir, 35100

  • GSK Investigational Site

    Sıhhiye/Ankara, 06100

Other trials in Turkey (Türkiye)

Philippines2 sites

  • GSK Investigational Site

    Manila, 1003

  • GSK Investigational Site

    Quezon City, 1101

Other trials in Philippines

Puerto Rico2 sites

  • GSK Investigational Site

    Ponce, Puerto Rico, 00716

  • GSK Investigational Site

    Santurce, Puerto Rico, 00907

Other trials in Puerto Rico

Iceland1 site

  • GSK Investigational Site

    Reykjavik, 101

Other trials in Iceland

Location not given1 site

  • GSK Investigational Site

About this study

Official title: A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia

This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

Read the detailed description

A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.

Being tested
dutasteride 0.5mg once daily for 4 years, tamsulosin 0.4mg once daily for 4 years
Keywords
Combination Therapy, dutasteride, BPH
Medical subject headings
Prostatic Hyperplasia

What participants receive

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

  • dutasteride 0.5mg once daily for 4 yearsDrug

    combination or single agent

  • tamsulosin 0.4mg once daily for 4 yearsDrug

    Also called dutasteride, tamsulosin

    combination agent or single agent

Study groups in NCT00090103
Study groupRoleWhat they receive
dutasterideActive comparatordutasteride 0.5mg once daily
Receives: Drug: dutasteride 0.5mg once daily for 4 years
ComboExperimentalCombination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily
Receives: Drug: dutasteride 0.5mg once daily for 4 years; Drug: tamsulosin 0.4mg once daily for 4 years
tamsulosinActive comparatortamsulosin 0.4mg once daily
Receives: Drug: tamsulosin 0.4mg once daily for 4 years

What is being measured

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

  1. Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.

    A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.

    Measured: Years 1, 2, 3, and 4

  2. Number of Participants With AUR or BPH-related Surgery

    A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.

    Measured: Baseline (Day 1) through Year 4

Secondary outcomes (29)

  1. Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4

    The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond.

    Measured: Years 1, 2, 3, and 4

  2. The Number of Participants With Each of the Five Components of BPH Clinical Progression

    The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.

    Measured: Baseline (Day 1) to Year 4

  3. Number of Events of Symptom Deterioration at the Indicated Time Periods

    The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35).

    Measured: Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)

  4. Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria

    A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories.

    Measured: Baseline (Day 1) through Year 4

  5. Number of Participants With an Event of Post-baseline BPH-related Hematospermia

    A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories.

    Measured: Baseline (Day 1) through Year 4

  6. Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48

    The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS.

    Measured: Baseline and Months 12, 24, 36, and 48

  7. Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48

    Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax.

    Measured: Baseline and Months 12, 24, 36, and 48

  8. Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48

    Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline.

    Measured: Baseline and Months 12, 24, 36, and 48

  9. Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48

    Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = [(post-BL - BL)/BL value] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL.

    Measured: Baseline and Months 12, 24, 36, and 48

  10. Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit

    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit?" If the answer to the question was "yes," the number of visits was recorded.

    Measured: Every 3 months from Month 3 to Month 48

  11. Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.

    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: "Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?". If the answer to the question was "yes," the number of Yes responses was recorded.

    Measured: Every 3 months from Month 3 to Month 48

  12. Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit

    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of visits was recorded.

    Measured: Every 3 months from Month 3 to Month 48

  13. Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"

    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: "Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?". If the answer to the question was "yes," the number of Yes responses was recorded.

    Measured: Every 3 months from Month 3 to Month 48

  14. Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)

    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?". If the answer to the question was "yes," the number of visits was recorded.

    Measured: Every 3 months from Month 3 to Month 48

  15. Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)

    At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: "Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?". If the answer to the question was "yes," the number of visits was recorded.

    Measured: Every 3 months from Month 3 to Month 48

  16. Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48

    The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII.

    Measured: Baseline and Months 12, 24, 36, and 48

  17. Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48

    The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status.

    Measured: Baseline and Months 12, 24, 36, 48

  18. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has control of your urinary problems changed?".

    Measured: Baseline and Months 12, 24, 36, and 48

  19. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on control of your urinary problems?" Satisfact., satisfaction.

    Measured: Baseline and Months 12, 24, 36, and 48

  20. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has the strength of your urinary stream changed?".

    Measured: Baseline and Months 12, 24, 36, and 48

  21. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect of the study medication on the strength of your urinary stream?". Satisfact., satisfaction.

    Measured: Baseline and Months 12, 24, 36, and 48

  22. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has your pain prior to urinating changed?".

    Measured: Baseline and Months 12, 24, 36, and 48

  23. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain prior to urinating?". Satisfact., satisfaction.

    Measured: Baseline and Months 12, 24, 36, and 48

  24. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has your pain during urination changed?".

    Measured: Baseline and Months 12, 24, 36, and 48

  25. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your pain during urination?". Satisfact., satisfaction.

    Measured: Baseline and Months 12, 24, 36, and 48

  26. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?".

    Measured: Baseline and Months 12, 24, 36, and 48

  27. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?". Satisfact., satisfaction.

    Measured: Baseline and Months 12, 24, 36, and 48

  28. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Overall, how satisfied are you with the study medication and it's effect on your urinary problems?". Satisfact., satisfaction.

    Measured: Baseline and Months 12, 24, 36, and 48

  29. Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)

    This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of "Would you ask your doctor for the medication you received in this study?".

    Measured: Baseline and Months 12, 24, 36, and 48

Timeline

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

  1. First posted26 Aug 2004 (estimated)
  2. Study startNov 2003
  3. Primary completionApr 2009
  4. Study completionApr 2009

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,844 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00090103
Sponsor's protocol ID
ARI40005
Status last verified
Jan 2017
First submitted
24 Aug 2004
Last updated
28 Feb 2017

Publications

  • Antonanzas F, Brenes F, Molero JM, Fernandez-Pro A, Huerta A, Palencia R, Cozar JM. [Cost-effectiveness of the combination therapy of dutasteride and tamsulosin in the treatment of benign prostatic hyperlasia in Spain]. Actas Urol Esp. 2011 Feb;35(2):65-71. doi: 10.1016/j.acuro.2010.11.008. Epub 2011 Jan 26. Spanish.

    PubMed 21269736

  • Barkin J, Roehrborn CG, Siami P, Haillot O, Morrill B, Black L, Montorsi F; CombAT Study Group. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial. BJU Int. 2009 Apr;103(7):919-26. doi: 10.1111/j.1464-410X.2009.08196.x. Epub 2009 Feb 23.

    PubMed 19239460

  • Bjerklund Johansen TE, Baker TM, Black LK. Cost-effectiveness of combination therapy for treatment of benign prostatic hyperplasia: a model based on the findings of the Combination of Avodart and Tamsulosin trial. BJU Int. 2012 Mar;109(5):731-8. doi: 10.1111/j.1464-410X.2011.10511.x. Epub 2011 Sep 20.

    PubMed 21933326

  • Black L, Grove A, Morrill B. The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms. Health Qual Life Outcomes. 2009 Jun 19;7:55. doi: 10.1186/1477-7525-7-55.

    PubMed 19545384

  • Chung BH, Roehrborn CG, Siami P, Major-Walker K, Morrill BB, Wilson TH, Montorsi F. Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH. Prostate Cancer Prostatic Dis. 2009;12(2):152-9. doi: 10.1038/pcan.2008.49. Epub 2008 Sep 23.

    PubMed 18813219

  • Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010 Jan;57(1):123-31. doi: 10.1016/j.eururo.2009.09.035. Epub 2009 Sep 19.

    PubMed 19825505

  • Roehrborn CG, Andriole GL, Wilson TH, Castro R, Rittmaster RS. Effect of dutasteride on prostate biopsy rates and the diagnosis of prostate cancer in men with lower urinary tract symptoms and enlarged prostates in the Combination of Avodart and Tamsulosin trial. Eur Urol. 2011 Feb;59(2):244-9. doi: 10.1016/j.eururo.2010.10.040. Epub 2010 Nov 4.

    PubMed 21093145

  • Roehrborn CG, Barkin J, Siami P, Tubaro A, Wilson TH, Morrill BB, Gagnier RP. Clinical outcomes after combined therapy with dutasteride plus tamsulosin or either monotherapy in men with benign prostatic hyperplasia (BPH) by baseline characteristics: 4-year results from the randomized, double-blind Combination of Avodart and Tamsulosin (CombAT) trial. BJU Int. 2011 Mar;107(6):946-54. doi: 10.1111/j.1464-410X.2011.10124.x. Epub 2011 Feb 18.

    PubMed 21332630

  • Roehrborn CG, Wilson TH, Black LK. Quantifying the contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia: 4-year data from the CombAT trial. J Urol. 2012 May;187(5):1732-8. doi: 10.1016/j.juro.2011.12.083. Epub 2012 Mar 15.

    PubMed 22425127

  • Becher E, Roehrborn CG, Siami P, Gagnier RP, Wilson TH, Montorsi F. The effects of dutasteride, tamsulosin, and the combination on storage and voiding in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the Combination of Avodart and Tamsulosin study. Prostate Cancer Prostatic Dis. 2009;12(4):369-74. doi: 10.1038/pcan.2009.37. Epub 2009 Sep 1.

    PubMed 19901936

  • Montorsi F, Roehrborn C, Garcia-Penit J, Borre M, Roeleveld TA, Alimi JC, Gagnier P, Wilson TH. The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study. BJU Int. 2011 May;107(9):1426-31. doi: 10.1111/j.1464-410X.2011.10129.x. Epub 2011 Feb 23.

    PubMed 21348912

  • Montorsi F, Henkel T, Geboers A, Mirone V, Arrosagaray P, Morrill B, Black L. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study. Int J Clin Pract. 2010 Jul;64(8):1042-51. doi: 10.1111/j.1742-1241.2010.02428.x. Epub 2010 May 7.

    PubMed 20487046

  • Haillot O, Fraga A, Maciukiewicz P, Pushkar D, Tammela T, Hofner K, Chantada V, Gagnier P, Morrill B. The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic BPH: 4-year post hoc analysis of European men in the CombAT study. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):302-6. doi: 10.1038/pcan.2011.13. Epub 2011 Apr 19.

    PubMed 21502969

  • Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. doi: 10.1016/j.juro.2007.09.084. Epub 2007 Dec 21.

    PubMed 18082216

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dutasteride 0.5mg once daily for 4 years and tamsulosin 0.4mg once daily for 4 years in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 503 sites in 37 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 28 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 503 sites in United States, France, Germany, Spain, Canada 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. 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?

Yes. Results are posted in the registry (first posted 16 Mar 2010). 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 Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. (time frame: Years 1, 2, 3, and 4). 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 NCT00090103, which also lists 14 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 28 Feb 2017.

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