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A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127179
First Posted: August 5, 2005
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.

Condition Intervention Phase
Benign Prostatic Hyperplasia Drug: MK0906, finasteride / Duration of Treatment: 48 weeks Drug: Comparator: placebo / Duration of Treatment: 48 weeks Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline in the International Prostate Symptom Score

Secondary Outcome Measures:
  • Change from baseline in QOL - index
  • Change from baseline in maximum urinary flow rate, %
  • Change from baseline in Prostate volume

Enrollment: 600
Actual Study Start Date: January 1, 2004
Study Completion Date: July 25, 2005
Primary Completion Date: July 1, 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with benign prostatic hyperplasia

Exclusion Criteria:

  • Patients who are suspected to be suffering from prostatic cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127179


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00127179     History of Changes
Other Study ID Numbers: 0906-140
MK0906-140
2005_042
First Submitted: August 3, 2005
First Posted: August 5, 2005
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Finasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents