Prostatic Hyperplasia Clinical Trial
Official title:
Long-Term, Efficacy and Safety of Alfuzosin 10 MG OD on the Risk of Acute Urinary Retention and the Need for Surgery in Patients With BPH. A Two Year, Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study.
| Verified date | June 2008 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
A study to determine the effect on prevention of Acute Urinary Retention (inability to
urinate) in males with an enlarged prostate, also known as BPH.
- Free study-related medical care provided.
| Status | Completed |
| Enrollment | 1522 |
| Est. completion date | March 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 55 Years and older |
| Eligibility |
- Has been suffering for at least 6 months with any of the following symptoms: - daytime or nighttime urinary frequency - urgent feeling to urinate - difficulty starting urinary stream - interruption of urinary stream - feeling of incomplete urination - Has not had a previous episode of acute urinary retention - Has not been diagnosed with prostate cancer - Has not had previous prostate surgery - Is not an insulin-dependent diabetic |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Australia | Sanofi-aventis Administrative Office | Macquarie Park | |
| Bulgaria | Sanofi-aventis Administrative Office | Sofia | |
| Canada | Sanofi-aventis Administrative Office | Laval | |
| Denmark | Sanofi-aventis Administrative Office | Horsholm | |
| Finland | Sanofi-aventis Administrative Office | Helsinki | |
| Greece | Sanofi-aventis Administrative Office | Athens | |
| Hungary | Sanofi-aventis Administrative Office | Budapest | |
| Israel | Edith Wolfson Hospital | Holon | |
| Israel | Sapir Med. Center - Meir General Hospital | Kfar Saba | |
| Israel | Rabin Medical Center-Golda Campus | Petah Tikvah | |
| Israel | Sourasky Med. Center-Ichilov Hospital | Tel Aviv | |
| Netherlands | Sanofi-aventis Administrative Office | Gouda | |
| Norway | Sanofi-aventis Administrative Office | Lysaker | |
| Poland | Sanofi-aventis Administrative Office | Warszawa | |
| Portugal | Sanofi-aventis Administrative Office | Porto Salvo | |
| Romania | Sanofi-aventis Administrative Office | Bucuresti | |
| South Africa | Sanofi-aventis Administrative Office | Midrand | |
| Spain | Sanofi-aventis Administrative Office | Barcelona | |
| Sweden | Sanofi-aventis Administrative Office | Bromma | |
| United States | Urology Research Options | Aurora | Colorado |
| United States | South Florida Medical Research | Aventura | Florida |
| United States | Maryland Prostate Cancer | Baltimore | Maryland |
| United States | Northwestern Center for Clinical Research | Chicago | Illinois |
| United States | Tampa Bay Medical Research, Inc. | Clearwater | Florida |
| United States | nTouch Research Corporation | Dallas | Texas |
| United States | Advanced Clinical Trials | Eugene | Oregon |
| United States | Welborn Clinic | Evansville | Indiana |
| United States | Northeast Indiana Research | Fort Wayne | Indiana |
| United States | Urology Associates | Fredericksburg | Virginia |
| United States | Matrix Research | Greenville | South Carolina |
| United States | Medical Affiliated Research Center, Inc | Huntsville | Alabama |
| United States | Urology of Indiana, LLC | Indianapolis | Indiana |
| United States | San Diego Urology Center | La Mesa | California |
| United States | University of Wisconsin Hospital & Clinics | Madison | Wisconsin |
| United States | Urology Associates | Marietta | Georgia |
| United States | Ut Medical Group, Inc. | Memphis | Tennessee |
| United States | Midwest Research Specialists, LLC | Milwaukee | Wisconsin |
| United States | Murfreesboro Medical Center | Murfreesboro | Tennessee |
| United States | Advanced Research Institute | New Port Richey | Florida |
| United States | Weill Cornell Medical Center | New York | New York |
| United States | Newton Wellesley Urology | Newton | Massachusetts |
| United States | Renstar Medical Research | Ocala | Florida |
| United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
| United States | Renstar Medical Research | Plantation | Florida |
| United States | Urology Consultants, P.A. | San Antonio | Texas |
| United States | San Bernardino Urology Associates | San Bernardino | California |
| United States | San Diego Urological Medical Group | San Diego | California |
| United States | Pacific Clinical Research | Santa Monica | California |
| United States | Jeffrey Frankel | Seattle | Washington |
| United States | Se Urology Network | Southaven | Mississippi |
| United States | Lakeside Urology, P.C. | St. Joseph | Michigan |
| United States | Maryland Urology Association | Towson | Maryland |
| United States | Connecticut Clinical Research Center | Waterbury | Connecticut |
| United States | Center for Urologic Care | West Reading | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States, Australia, Bulgaria, Canada, Denmark, Finland, Greece, Hungary, Israel, Netherlands, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden,
Roehrborn CG. Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: results of a 2-year placebo-controlled study. BJU Int. 2006 Apr;97(4):734-41. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | occurrence of first episode of acute urinary retention (AUR) | |||
| Secondary | need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS) |
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