A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
- Registration Number
- NCT00224120
- Lead Sponsor
- Watson Pharmaceuticals
- Brief Summary
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
- Detailed Description
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 462
Inclusion Criteria
- Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH.
Exclusion Criteria
- Medical conditions that would confound the efficacy evaluation.
- Medical conditions in which it would be unsafe to use an alpha-blocker.
- The use of concomitant drugs that would confound the efficacy evaluation.
- The use of concomitant drugs that would be unsafe with this alpha-blocker.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Silodosin Silodosin Silodosin 8 mg/Day with food Placebo Placebo Matching placebo capsule once daily with food
- Primary Outcome Measures
Name Time Method Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks Baseline and 12 weeks International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms
- Secondary Outcome Measures
Name Time Method Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks Baseline and 12 weeks