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A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia

Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: MK0906, finasteride / Duration of Treatment: 48 weeks (Drug); Comparator: placebo / Duration of Treatment: 48 weeks (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Summary

The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.

Clinical Details

Official title: MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in the International Prostate Symptom Score

Secondary outcome:

Change from baseline in QOL - index

Change from baseline in maximum urinary flow rate, %

Change from baseline in Prostate volume

Eligibility

Minimum age: 50 Years. Maximum age: 79 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Patients with benign prostatic hyperplasia

Exclusion Criteria:

- Patients who are suspected to be suffering from prostatic cancer

Locations and Contacts

Call for Site Information, Tokyo, Chuoku 103-8416, Japan
Additional Information

Starting date: January 2004
Last updated: June 2, 2006

Page last updated: June 20, 2008

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