A Multi-Center, Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 661
- Primary Endpoint
- Adverse Events
Study Overview
Brief Summary
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
Detailed Description
This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance.
All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.
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 per day with food
Intervention: Silodosin (Drug)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 9 months
All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.
Secondary Outcomes
- International Prostate Symptom Score (IPSS)(9 months)