CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 461 enrolled
Drug / intervention
Silodosin +1 moredrug
Likely dose
Silodosin 8 mg orally once dailyAI-extracted
Key inclusion· 3
  • ✓Males at least 50 years of age
  • ✓Symptoms of moderate to severe benign prostatic hyperplasia
  • ✓Good general health
Key exclusion· 4
  • ✕Medical conditions that would confound the efficacy evaluation
  • ✕Medical conditions in which it would be unsafe to use an alpha-blocker
  • ✕Concomitant drugs that would confound the efficacy evaluation
  • ✕Concomitant drugs that would be unsafe with alpha-blockers

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00224107
NCT00224107Phase 3Completed
CompareCT.gov

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

Watson Pharmaceuticals·interventional·Posted Sep 22, 2005·Updated Jul 12, 2011

In Brief

A Phase 3 clinical trial evaluating Silodosin and Placebo for Benign Prostatic Hyperplasia (BPH). Completed, enrolled 461 participants across 43 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia (BPH)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartMay 1, 2005
Primary CompletionAug 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.8 years ago

Interventions

Silodosindrug

8 mg daily for 12 weeks

Placeboother

1 capsule daily for 12 weeks