A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Overview
- Phase
- Phase 3
- Intervention
- Silodosin
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- Watson Pharmaceuticals
- Enrollment
- 462
- Primary Endpoint
- Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Silodosin
Silodosin 8 mg/Day with food
Intervention: Silodosin
Placebo
Matching placebo capsule once daily with food
Intervention: Placebo
Outcomes
Primary Outcomes
Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
Time Frame: 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 Outcomes
- Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks(Baseline and 12 weeks)