Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
|ClinicalTrials.gov Identifier: NCT00347061|
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : October 2, 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.
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Drug: afuzosin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||May 2006|
|Primary Completion Date :||October 2007|
|Study Completion Date :||October 2007|
- One year safety data of SL77.0499-10
- One year efficacy data and plasma concentration of SL77.0499-10
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347061
|Study Director:||ICD CSD||Sanofi|