Phase 3
N=462
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT00224120 ↗Enrolled (actual)
462
Serious AEs
1.5%
Results posted
Dec 2009
Primary outcome: Primary: Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks — 21.2; 21.2; -6.3; -3.4 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Silodosin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Watson Pharmaceuticals
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks |
21.2; 21.2; -6.3; -3.4 | — |
| SECONDARY Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks |
8.4; 8.7; 2.9; 1.9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00224120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.