Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
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
1 other identifier
interventional
4,844
34 countries
495
Brief 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). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2003
Longer than P75 for phase_3
495 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 24, 2004
CompletedFirst Posted
Study publicly available on registry
August 26, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
March 16, 2010
CompletedFebruary 28, 2017
January 1, 2017
5.4 years
August 24, 2004
February 26, 2010
January 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Years 1, 2, 3, and 4
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.
Baseline (Day 1) through Year 4
Secondary Outcomes (29)
Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4
Years 1, 2, 3, and 4
The Number of Participants With Each of the Five Components of BPH Clinical Progression
Baseline (Day 1) to Year 4
Number of Events of Symptom Deterioration at the Indicated Time Periods
Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)
Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria
Baseline (Day 1) through Year 4
Number of Participants With an Event of Post-baseline BPH-related Hematospermia
Baseline (Day 1) through Year 4
- +24 more secondary outcomes
Study Arms (3)
dutasteride
ACTIVE COMPARATORdutasteride 0.5mg once daily
Combo
EXPERIMENTALCombination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily
tamsulosin
ACTIVE COMPARATORtamsulosin 0.4mg once daily
Interventions
combination agent or single agent
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (503)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Birmingham, Alabama, 35234, United States
GSK Investigational Site
Birmingham, Alabama, 35242, United States
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Columbiana, Alabama, 35051, United States
GSK Investigational Site
Hoover, Alabama, 35216, United States
GSK Investigational Site
Anchorage, Alaska, 99508, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Phoenix, Arizona, Arizona, 86106, United States
GSK Investigational Site
Beverly Hills, California, 90212, United States
GSK Investigational Site
Concord, California, 94520, United States
GSK Investigational Site
Glendora, California, 91741, United States
GSK Investigational Site
Greenbrae, California, 94904, United States
GSK Investigational Site
Irvine, California, 92618, United States
GSK Investigational Site
La Jolla, California, 92093, United States
GSK Investigational Site
Laguna Woods, California, 92637, United States
GSK Investigational Site
Los Angelas, California, 90017, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Los Angeles, California, 90057, United States
GSK Investigational Site
Modesto, California, 95350, United States
GSK Investigational Site
Sacramento, California, 95821, United States
GSK Investigational Site
San Diego, California, 91405, United States
GSK Investigational Site
San Diego, California, 92103, United States
GSK Investigational Site
San Diego, California, 92108, United States
GSK Investigational Site
Torrance, California, 90506, United States
GSK Investigational Site
Vista, California, 92084, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Bay Pines, Florida, 33744, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Daytona Beach, Florida, 32114, United States
GSK Investigational Site
Lake Worth, Florida, 33461, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
New Smyrna Beach, Florida, 32168, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Orange City, Florida, 32763, United States
GSK Investigational Site
Pensacola, Florida, 32503, United States
GSK Investigational Site
Pinecrest, Florida, 33156, United States
GSK Investigational Site
Saint Augustine, Florida, 32086, United States
GSK Investigational Site
Spring Hill, Florida, 34609, United States
GSK Investigational Site
St. Petersburg, Florida, 33702, United States
GSK Investigational Site
St. Petersburg, Florida, 33710, United States
GSK Investigational Site
Stuart, Florida, 34996, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Wellington, Florida, 33414, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Blue Ridge, Georgia, 30513, United States
GSK Investigational Site
Calhoun, Georgia, 30701, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Marietta, Georgia, 30066, United States
GSK Investigational Site
Meridian, Idaho, 83642, United States
GSK Investigational Site
Belleville, Illinois, 62220, United States
GSK Investigational Site
Peoria, Illinois, 61602, United States
GSK Investigational Site
Peoria, Illinois, 61614, United States
GSK Investigational Site
Wheaton, Illinois, 60187, United States
GSK Investigational Site
Winfield, Illinois, 60190, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Jeffersonville, Indiana, 47130, United States
GSK Investigational Site
Newburgh, Indiana, 47630, United States
GSK Investigational Site
South Bend, Indiana, 46601, United States
GSK Investigational Site
Des Moines, Iowa, 50309, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Murray, Kentucky, 42071, United States
GSK Investigational Site
Bossier City, Louisiana, 71111, United States
GSK Investigational Site
Laurel, Maryland, 20724, United States
GSK Investigational Site
Minneapolis, Minnesota, 55417, United States
GSK Investigational Site
Picayune, Mississippi, 39466, United States
GSK Investigational Site
Kansas City, Missouri, 64114, United States
GSK Investigational Site
Missoula, Montana, 59802, United States
GSK Investigational Site
Omaha, Nebraska, 68102, United States
GSK Investigational Site
Henderson, Nevada, 89014, United States
GSK Investigational Site
Hillsborough, New Jersey, 08844, United States
GSK Investigational Site
Perth Amboy, New Jersey, 08861, United States
GSK Investigational Site
Somerville, New Jersey, 08876, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Bay Shore, New York, 11706, United States
GSK Investigational Site
Garden City, New York, 11530, United States
GSK Investigational Site
Great Neck, New York, 11021, United States
GSK Investigational Site
Lewiston, New York, 14092, United States
GSK Investigational Site
Asheboro, North Carolina, 27203, United States
GSK Investigational Site
Cary, North Carolina, 27511, United States
GSK Investigational Site
Charlotte, North Carolina, 28262, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Fayetteville, North Carolina, 28304, United States
GSK Investigational Site
Greensboro, North Carolina, 27403, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Bismarck, North Dakota, 58501, United States
GSK Investigational Site
Bellbrook, Ohio, 45305, United States
GSK Investigational Site
Cincinnati, Ohio, 45249, United States
GSK Investigational Site
Columbus, Ohio, 43212, United States
GSK Investigational Site
Columbus, Ohio, 43214, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
GSK Investigational Site
Fleetwood, Pennsylvania, 19522, United States
GSK Investigational Site
Providence, Rhode Island, 02904, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Athes, Texas, 75751, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75234, United States
GSK Investigational Site
Dallas, Texas, 75390, United States
GSK Investigational Site
Fort Worth, Texas, 76107, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
New Brunfels, Texas, 78130, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Temple, Texas, 76508, United States
GSK Investigational Site
Texarkana, Texas, 75503, United States
GSK Investigational Site
Salt Lake City, Utah, 84132, United States
GSK Investigational Site
Alexandria, Virginia, 22304, United States
GSK Investigational Site
Bellevue, Washington, 98004, United States
GSK Investigational Site
Mountlake Terrace, Washington, 98043, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Buenos Aires, Buenos Aires, 1120, Argentina
GSK Investigational Site
Buenos Aires, Buenos Aires, 1416, Argentina
GSK Investigational Site
Buenos Aires, 1111, Argentina
GSK Investigational Site
Buenos Aires, 1405, Argentina
GSK Investigational Site
Buenos Aires, C1181ACI, Argentina
GSK Investigational Site
Ciudad de Buenos Aires, 1118, Argentina
GSK Investigational Site
Antwerp, 2020, Belgium
GSK Investigational Site
Brussels, 1070, Belgium
GSK Investigational Site
Brussels, 1090, Belgium
GSK Investigational Site
Edegem, 2650, Belgium
GSK Investigational Site
Genk, 3600, Belgium
GSK Investigational Site
La Louvière, 7100, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Roeselare, 8800, Belgium
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30130-008, Brazil
GSK Investigational Site
Rio de Janeiro, Rio de Janeiro, 20 551-030, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90470-340, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
GSK Investigational Site
São Paulo, São Paulo, 04262-000, Brazil
GSK Investigational Site
Pleven, 5800, Bulgaria
GSK Investigational Site
Sofia, 1000, Bulgaria
GSK Investigational Site
Sofia, 1431/1000, Bulgaria
GSK Investigational Site
Sofia, 1606, Bulgaria
GSK Investigational Site
Varna, 9002, Bulgaria
GSK Investigational Site
Surrey, British Columbia, V3V 1N1, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3C 0N2, Canada
GSK Investigational Site
Saint John, New Brunswick, E2L 4L2, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1B 4S8, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3H 3A7, Canada
GSK Investigational Site
Kentville, Nova Scotia, B4N 4K9, Canada
GSK Investigational Site
Barrie, Ontario, L4M 7G1, Canada
GSK Investigational Site
Brantford, Ontario, N3R 4N3, Canada
GSK Investigational Site
Courtice, Ontario, L1E 3C3, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 4T3, Canada
GSK Investigational Site
Guelph, Ontario, N1H 5J1, Canada
GSK Investigational Site
Hamilton, Ontario, L8N 4A6, Canada
GSK Investigational Site
Kingston, Ontario, K7L 2V7, Canada
GSK Investigational Site
London, Ontario, M6A 4G5, Canada
GSK Investigational Site
London, Ontario, N6A 4V2, Canada
GSK Investigational Site
North Bay, Ontario, P1B 7K8, Canada
GSK Investigational Site
Oakville, Ontario, L6H 3P1, Canada
GSK Investigational Site
Oshawa, Ontario, L1H 7K4, Canada
GSK Investigational Site
Ottawa, Ontario, K1Y 4E9, Canada
GSK Investigational Site
Scarborough Village, Ontario, M1P 2T7, Canada
GSK Investigational Site
Scarborough Village, Ontario, M1S 4V5, Canada
GSK Investigational Site
Toronto, Ontario, M2K 2W1, Canada
GSK Investigational Site
Toronto, Ontario, M4C 5T2, Canada
GSK Investigational Site
Toronto, Ontario, M5T 2S8, Canada
GSK Investigational Site
Toronto, Ontario, M6A 3B5, Canada
GSK Investigational Site
Toronto, Ontario, M6S 4W4, Canada
GSK Investigational Site
Montreal, Quebec, H2X 1N8, Canada
GSK Investigational Site
Montreal, Quebec, H3A 1A1, Canada
GSK Investigational Site
Montreal, Quebec, H3S 1Z1, Canada
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
GSK Investigational Site
Saint-Jérôme, Quebec, J7Z 5T3, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 5N4, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G9A 3V7, Canada
GSK Investigational Site
Hradec Králové, 536 00, Czechia
GSK Investigational Site
Ostrava - Poruba, 708 52, Czechia
GSK Investigational Site
Prague, 130 00, Czechia
GSK Investigational Site
Prague, 150 18, Czechia
GSK Investigational Site
Prague, 180 71, Czechia
GSK Investigational Site
Roudnice nad Labem, 413 01, Czechia
GSK Investigational Site
Aalborg, 9100, Denmark
GSK Investigational Site
Aarhus N, 8200, Denmark
GSK Investigational Site
Fredericia, 7000, Denmark
GSK Investigational Site
Randers, 8900, Denmark
GSK Investigational Site
Tallinn, 1162, Estonia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Tartu, Estonia
GSK Investigational Site
Helsinki, 00150, Finland
GSK Investigational Site
Jakobstad, 68600, Finland
GSK Investigational Site
Kouvola, 45200, Finland
GSK Investigational Site
Kuopio, 70100, Finland
GSK Investigational Site
Tampere, 33520, Finland
GSK Investigational Site
Bully-les-Mines, Hauts-de-France, 62160, France
GSK Investigational Site
Agny, 62217, France
GSK Investigational Site
Angers, 49000, France
GSK Investigational Site
Annecy, 74000, France
GSK Investigational Site
Arras, 62000, France
GSK Investigational Site
Athis-Mons, 91200, France
GSK Investigational Site
Besançon, 25000, France
GSK Investigational Site
Bouchemaine, 49080, France
GSK Investigational Site
Broglie, 27270, France
GSK Investigational Site
Castelneau Le Nez, 34170, France
GSK Investigational Site
Chambéry, 73000, France
GSK Investigational Site
Chilly-Mazarin, 91380, France
GSK Investigational Site
Cournonterral, 34460, France
GSK Investigational Site
Créteil, 94010, France
GSK Investigational Site
Domarin, 38300, France
GSK Investigational Site
Épinay-sur-Orge, 91360, France
GSK Investigational Site
Évreux, 27000, France
GSK Investigational Site
Évreux, 27025, France
GSK Investigational Site
Gif-sur-Yvette, 91190, France
GSK Investigational Site
Grenoble, 38100, France
GSK Investigational Site
La Seyne-sur-Mer, 83500, France
GSK Investigational Site
Lamarque, 33460, France
GSK Investigational Site
Laval, 53000, France
GSK Investigational Site
Le Brusc, 83140, France
GSK Investigational Site
Le Kremlin-Bicêtre, 94275, France
GSK Investigational Site
Les Mureaux, 78130, France
GSK Investigational Site
Lesparre-Médoc, 33340, France
GSK Investigational Site
Linas, 91310, France
GSK Investigational Site
Longpont-sur-Orge, 91310, France
GSK Investigational Site
Lyon, 69008, France
GSK Investigational Site
Melun, 77007, France
GSK Investigational Site
Meudon, 92190, France
GSK Investigational Site
Meylan, 38240, France
GSK Investigational Site
Mont-de-Marsan, 40000, France
GSK Investigational Site
Montauban, 82017, France
GSK Investigational Site
Montpelier, 34000, France
GSK Investigational Site
Montpellier, 34000, France
GSK Investigational Site
Montpellier, 34100, France
GSK Investigational Site
Orléans, 45067, France
GSK Investigational Site
Paris, 75019, France
GSK Investigational Site
Pontonx Sur Adour, 40465, France
GSK Investigational Site
Roanne, 42300, France
GSK Investigational Site
Saint-Chamond, 42400, France
GSK Investigational Site
Saint-Denis, 93200, France
GSK Investigational Site
Saint-Egrève, 38120, France
GSK Investigational Site
Saint-Galmier, 42330, France
GSK Investigational Site
Saint-Georges-dOrques, 34680, France
GSK Investigational Site
Saint-Germain-Lespinasse, 42640, France
GSK Investigational Site
Saint-Sébastien-de-Morsent, 27180, France
GSK Investigational Site
Sainte-Suzanne, 53270, France
GSK Investigational Site
Sanary-sur-Mer, 83110, France
GSK Investigational Site
Sarlat-la-Canéda, 24200, France
GSK Investigational Site
Seysses, 31600, France
GSK Investigational Site
Six-Fours-les-Plages, 83140, France
GSK Investigational Site
Suresnes, 92151, France
GSK Investigational Site
Toulon, 83200, France
GSK Investigational Site
Tours, 37044, France
GSK Investigational Site
Vaucresson, 92420, France
GSK Investigational Site
Verneuil-sur-Seine, 78480, France
GSK Investigational Site
Villejuif, 94804, France
GSK Investigational Site
Villeneuve-lès-Maguelone, 34750, France
GSK Investigational Site
Vourey, 38210, France
GSK Investigational Site
Aalen, Baden-Wurttemberg, 73430, Germany
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
GSK Investigational Site
Konstanz, Baden-Wurttemberg, 78464, Germany
GSK Investigational Site
Mosbach, Baden-Wurttemberg, 74821, Germany
GSK Investigational Site
Rottweil, Baden-Wurttemberg, 78628, Germany
GSK Investigational Site
Stockach, Baden-Wurttemberg, 78333, Germany
GSK Investigational Site
Aichach, Bavaria, 86551, Germany
GSK Investigational Site
Amberg, Bavaria, 92224, Germany
GSK Investigational Site
Augsburg, Bavaria, 86150, Germany
GSK Investigational Site
Graefeling, Bavaria, 82166, Germany
GSK Investigational Site
Neu-Ulm, Bavaria, 89231, Germany
GSK Investigational Site
Schongau, Bavaria, 86956, Germany
GSK Investigational Site
Wertingen, Bavaria, 86637, Germany
GSK Investigational Site
Hagenow, Brandenburg, 19230, Germany
GSK Investigational Site
Lauchhammer, Brandenburg, 01979, Germany
GSK Investigational Site
Oranienburg, Brandenburg, 16515, Germany
GSK Investigational Site
Senftenberg, Brandenburg, 01968, Germany
GSK Investigational Site
Hamburg, Hamburg, 20253, Germany
GSK Investigational Site
Hamburg, Hamburg, 22415, Germany
GSK Investigational Site
Alzenau, Hesse, 63755, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60326, Germany
GSK Investigational Site
Fulda, Hesse, 36037, Germany
GSK Investigational Site
Giessen, Hesse, 35390, Germany
GSK Investigational Site
Kassel, Hesse, 34123, Germany
GSK Investigational Site
Koenigstein, Hesse, 61462, Germany
GSK Investigational Site
Marburg, Hesse, 35039, Germany
GSK Investigational Site
Schwalbach, Hesse, 65824, Germany
GSK Investigational Site
Delmenhorst, Lower Saxony, 27753, Germany
GSK Investigational Site
Holzminden, Lower Saxony, 37603, Germany
GSK Investigational Site
Oldenburg, Lower Saxony, 26121, Germany
GSK Investigational Site
Osnabrück, Lower Saxony, 49074, Germany
GSK Investigational Site
Grimmen, Mecklenburg-Vorpommern, 18507, Germany
GSK Investigational Site
Parchim, Mecklenburg-Vorpommern, 19370, Germany
GSK Investigational Site
Dülmen, North Rhine-Westphalia, 48249, Germany
GSK Investigational Site
Stadtlohn, North Rhine-Westphalia, 48703, Germany
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068, Germany
GSK Investigational Site
Hohenstein-Ernsttal, Saxony, 09337, Germany
GSK Investigational Site
Leipzig, Saxony, 04105, Germany
GSK Investigational Site
Leipzig, Saxony, 04109, Germany
GSK Investigational Site
Leipzig, Saxony, 04277, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, 06114, Germany
GSK Investigational Site
Hettstedt, Saxony-Anhalt, 06333, Germany
GSK Investigational Site
Merseburg, Saxony-Anhalt, 06217, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, 25813, Germany
GSK Investigational Site
Kiel, Schleswig-Holstein, 24103, Germany
GSK Investigational Site
Berlin, State of Berlin, 10627, Germany
GSK Investigational Site
Berlin, State of Berlin, 10719, Germany
GSK Investigational Site
Berlin, State of Berlin, 12167, Germany
GSK Investigational Site
Berlin, State of Berlin, 12347, Germany
GSK Investigational Site
Berlin, State of Berlin, 12681, Germany
GSK Investigational Site
Berlin, State of Berlin, 13053, Germany
GSK Investigational Site
Berlin, State of Berlin, 13055, Germany
GSK Investigational Site
Berlin, State of Berlin, 13125, Germany
GSK Investigational Site
Berlin, State of Berlin, 13439, Germany
GSK Investigational Site
Berlin, State of Berlin, 14197, Germany
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Apolda, Thuringia, 99510, Germany
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Athens, 115 21, Greece
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Athens, 115 22, Greece
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Athens, 15126, Greece
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Athens, 154 52, Greece
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Pátrai, 265 00, Greece
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Polygyros, 63 100, Greece
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Thassaloniki, 564 34, Greece
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Budapest, 1036., Hungary
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Sopron, 9400, Hungary
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Székesfehérvár, 8000, Hungary
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Veszprém, 8200, Hungary
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Reykjavik, 101, Iceland
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Kfar Saba, 44281, Israel
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Catanzaro, Calabria, 88100, Italy
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Avellino, Campania, 83100, Italy
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Castellamare Di Stabia (NA), Campania, 80053, Italy
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Napoli, Campania, 80131, Italy
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San Felice A Cancello Caserta, Campania, 81027, Italy
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Torre Del Greco (NA), Campania, 80059, Italy
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Modena, Emilia-Romagna, 41100, Italy
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Udine, Friuli Venezia Giulia, 33100, Italy
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Rome, Lazio, 00189, Italy
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Ivrea (TO), Piedmont, 10015, Italy
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Portogruaro (VE), Veneto, 30026, Italy
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Kaunas, LT-49287, Lithuania
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Klaipėda, LT-92288, Lithuania
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Zapopan, Jalisco, Jalisco, 45100, Mexico
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Mexico City, 06720, Mexico
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Mexico City, 14050, Mexico
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México, 06700, Mexico
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Alkmaar, 1815 JD, Netherlands
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Amstelveen, 1186 AM, Netherlands
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Amsterdam, 1034 CS, Netherlands
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Amsterdam, 1105 AZ, Netherlands
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Arnhem, 6842 CV, Netherlands
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Doetinchem, 7009 BL, Netherlands
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Enschede, 7511JX, Netherlands
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Etten-Leur, 4872 LA, Netherlands
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Groningen, 9713 GZ, Netherlands
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Groningen, 9721 SW, Netherlands
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Heerlen, 6419 PC, Netherlands
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Maastricht, 6229 HX, Netherlands
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The Hague, 2566 MJ, Netherlands
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Zwijndrecht, 3331 LZ, Netherlands
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Ålesund, N-6026, Norway
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Bergen, 5094, Norway
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Haugesund, 5507, Norway
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Moelv, N-2390, Norway
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Nøtterøy, 3128, Norway
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Oslo, 0257 OSLO, Norway
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Oslo, 0514, Norway
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Porsgrunn, N-3922, Norway
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Tønsberg, 3116, Norway
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Manila, 1003, Philippines
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Gdansk, 80-402, Poland
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Krakow, 31-221, Poland
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Krakow, 31-826, Poland
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Lublin, 20-950, Poland
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Abrantes, 2200 Abrantes, Portugal
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Lisbon, 1269-098 Lisboa, Portugal
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Porto, 4099-004, Portugal
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Porto, 4150-113 PORTO, Portugal
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S. Martinho Do Bispo, 3040-316 Coimbra, Portugal
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Moscow, 109472, Russia
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Moscow, 117 837, Russia
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Banská Bystrica, 975 17, Slovakia
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Bratislava, 833 05, Slovakia
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Košice, 041 66, Slovakia
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Martin, 036 59, Slovakia
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Pusan, 602-739, South Korea
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Seoul, 135-710, South Korea
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Seoul, 135-720, South Korea
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Seoul, 138-736, South Korea
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Seoul, 150-015, South Korea
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A Coruña, 15006, Spain
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Alava, 01004, Spain
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Alcázar de San Juan (Ciudad Real), 13600, Spain
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Badajoz, 6080, Spain
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Barcelona, 08025, Spain
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Barcelona, 08221, Spain
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Ciudad Real, 13005, Spain
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Donostia / San Sebastian, 20012, Spain
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Elche (Alicante), 03202, Spain
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Gijón, 33394, Spain
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Guadalajara, 19002, Spain
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Jerez de la Frontera, 11407, Spain
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Langreo (Oviedo), 33920, Spain
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Las Palmas, 35020, Spain
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Las Palmas de Gran Canaria, 35016, Spain
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Madrid, 28006, Spain
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Madrid, 28016, Spain
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Manacor (Palma de Mallorca), Spain
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Mérida, 6800, Spain
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Bangkok, 10700, Thailand
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Istanbul, 34303, Turkey (Türkiye)
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Related Publications (14)
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.
PMID: 21269736BACKGROUNDBarkin 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.
PMID: 19239460BACKGROUNDBjerklund 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.
PMID: 21933326BACKGROUNDBlack 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.
PMID: 19545384BACKGROUNDChung 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.
PMID: 18813219BACKGROUNDRoehrborn 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.
PMID: 19825505BACKGROUNDRoehrborn 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.
PMID: 21093145BACKGROUNDRoehrborn 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.
PMID: 21332630BACKGROUNDRoehrborn 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.
PMID: 22425127BACKGROUNDBecher 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.
PMID: 19901936BACKGROUNDMontorsi 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.
PMID: 21348912BACKGROUNDMontorsi 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.
PMID: 20487046BACKGROUNDHaillot 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.
PMID: 21502969BACKGROUNDRoehrborn 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.
PMID: 18082216BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2004
First Posted
August 26, 2004
Study Start
November 1, 2003
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
February 28, 2017
Results First Posted
March 16, 2010
Record last verified: 2017-01