Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia
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|ClinicalTrials.gov Identifier: NCT00409357|
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : October 2, 2009
The primary objective is to assess the dose-response relationship of SL77.0499 10 (alfuzosin hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral administration period for the efficacy in patients with lower urinary tract symptoms (LUTS) related to BPH.
Secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with placebo and to assess the safety of each dose of alfuzosin.
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Drug: SL77.0499-10 (alfuzosin hydrochloride)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||473 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of SL77.0499-10 Once Daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH)|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||August 2005|
- The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit.
- Efficacy: changes from baseline in IPSS total score by visit;·IPSS irritative and obstructive subscores,·urinary peak flow rate and residual urine volume at EOS and by visit.
- Safety: adverse events, vital signs, laboratory tests.
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): NCT00409357
|Study Director:||ICD CSD||Sanofi|