drugset / Trial / NCT01534351

Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)

NCT01534351

Phase 3 Terminated 1 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is designed to compare safety and efficacy of monotherapy finasteride to combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic hyperplasia (BPH) who are at least 50 years of age or older. The primary hypotheses are that concomitantly-dosed finasteride 5 mg and tamsulosin 0.2 mg will be superior with respect to BPH symptoms compared to monotherapy with finasteride 5 mg as measured by change from baseline on the International Prostate Symptoms Score (IPSS) and will be superior with respect to prostate volume reduction compared to montherapy with tamsulosin 0.2 mg as measured by percent change from baseline in prostate volume.

Timeline

Start
2013-08-01
Primary completion
2013-11-18
Completion
2013-11-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Finasteride Small molecule 5 mg Oral
Subject Tamsulosin Other / unclassified 0.2 mg Oral