Trials / Completed
CompletedNCT00347061
Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
Primary: 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. Secondary: * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | afuzosin |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2007-10-01
- Completion
- 2007-10-01
- First posted
- 2006-07-04
- Last updated
- 2009-10-02
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00347061. Inclusion in this directory is not an endorsement.