Clinical Trial in Males With BPH (Enlarged Prostate)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00029822 |
Recruitment Status :
Completed
First Posted : January 24, 2002
Last Update Posted : June 9, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Retention Prostatic Hyperplasia Benign Prostatic Hypertrophy | Drug: Alfuzosin (SL770499) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1522 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
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. |
Study Start Date : | May 2001 |
Actual Study Completion Date : | March 2005 |

- occurrence of first episode of acute urinary retention (AUR)
- need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029822

Study Director: | ICD CSD | Sanofi |
Publications of Results:
Responsible Party: | ICD Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00029822 |
Other Study ID Numbers: |
EFC4485 SL770499 |
First Posted: | January 24, 2002 Key Record Dates |
Last Update Posted: | June 9, 2008 |
Last Verified: | June 2008 |
Acute Urinary Retention AUR Benign Prostatic Hyperplasia |
Benign Prostatic Hypertrophy BPH Enlarged Prostate |
Prostatic Hyperplasia Urinary Retention Hyperplasia Hypertrophy Pathologic Processes Prostatic Diseases Pathological Conditions, Anatomical Urination Disorders Urologic Diseases |
Alfuzosin Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |