Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
This study has been completed.
Information provided by:
First received: June 30, 2006
Last updated: October 1, 2009
Last verified: October 2009
To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.
- To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.
- To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled Study.|
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- One year safety data of SL77.0499-10
Secondary Outcome Measures:
- One year efficacy data and plasma concentration of SL77.0499-10
|Study Start Date:||May 2006|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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