Phase 3
Completed N=661
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
Source: ClinicalTrials.gov NCT00224133 ↗Enrolled (actual)
661
Serious AEs
4.4%
Results posted
Apr 2010
Primary outcomePrimary: Adverse Events — 431; 188; 29; 0 participants
Summary
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
431; 188; 29; 0; 86; 54 | — |
| SECONDARY International Prostate Symptom Score (IPSS) |
— | — |
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. Informational only — not medical advice.