Double-blind randomized study to compare the efficacy and safety of tamsulosin prolonged release tablet 0.4 mg with Harnal capsule 0.2 mg in patients with lower urinary tract symptoms (LUTS) associated with benign prostate hyperplasia (BPH)
Phase 3
- Conditions
- ower urinary tract symptoms, Benign prostate hyperplasia
- Registration Number
- JPRN-jRCT1080221287
- Lead Sponsor
- Astellas Pharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 400
Inclusion Criteria
A total I-PSS of 8 to 30
A maximum flow rate in range of 5-15 ml/s; Voided volume of 150 ml or over
Residual volume of 100ml or less
Prostate volume of 20ml or over
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method