Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
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|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|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
- One year safety data of SL77.0499-10
- One year efficacy data and plasma concentration of SL77.0499-10
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): NCT00347061
|Study Director:||ICD CSD||Sanofi|