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

NCT01534351 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-08-29

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01534351 on ClinicalTrials.gov