Phase 3
N=661
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
Benign Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT00224133 ↗Enrolled (actual)
661
Serious AEs
4.4%
Results posted
Apr 2010
Primary outcome: Primary: Adverse Events — 431; 188; 29; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Silodosin (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Watson Pharmaceuticals
- Primary completion
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
431; 188; 29; 0; 86; 54 | — |
| SECONDARY International Prostate Symptom Score (IPSS) |
— | — |
Summary
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00224133). 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.