CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 661 enrolled
Drug / intervention
Silodosindrug
Likely dose
Silodosin 8 mg dailyAI-extracted
Key inclusion· 3
  • ✓Males at least 50 years of age
  • ✓Completion of prior trial SI04009 or SI04010
  • ✓Good general health
Key exclusion· 4
  • ✕Medical conditions that would confound efficacy evaluation
  • ✕Medical conditions unsafe with alpha-blocker use
  • ✕Concomitant drugs that confound efficacy evaluation
  • ✕Concomitant drugs unsafe with this alpha-blocker

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

Search/NCT00224133
NCT00224133Phase 3Completed
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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

Watson Pharmaceuticals·interventional·Posted Sep 22, 2005·Updated Apr 27, 2010

In Brief

A Phase 3 clinical trial evaluating Silodosin for Benign Prostatic Hyperplasia. Completed, enrolled 661 participants across 79 sites.

Detailed Summary

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartSep 1, 2005
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.8 years ago

Interventions

Silodosindrug

8 mg daily