NCT01534351

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

A Phase III, Randomized Clinical Trial to Study the Safety and Efficacy of MK-906 (Finasteride) and Tamsulosin Administered Either Alone or Concomitantly in Patients With Benign Prostatic Hyperplasia (BPH)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Finasteride	Finasteride 5 mg oral tablet taken once daily.
DRUG	Tamsulosin	Tamsulosin 0.2 mg oral capsule taken once daily.
DRUG	Finasteride-matching placebo	Matching placebo to finasteride 5 mg oral tablet taken once daily.
DRUG	Tamsulosin-matching placebo	Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-11-18
• Completion: 2013-11-18
• First posted: 2012-02-16
• Last updated: 2018-08-29
• Results posted: 2015-12-03