Back to resultsA Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0906, finasteride / Duration of Treatment: 48 weeks
Comparator: placebo / Duration of Treatment: 48 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria: Patients with benign prostatic hyperplasia Exclusion Criteria: Patients who are suspected to be suffering from prostatic cancer
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00127179
Brief Title
A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)
Official Title
MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2004 (Actual)
Primary Completion Date
July 1, 2005 (Actual)
Study Completion Date
July 25, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0906, finasteride / Duration of Treatment: 48 weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo / Duration of Treatment: 48 weeks
Primary Outcome Measure Information:
Title
Change from baseline in the International Prostate Symptom Score
Secondary Outcome Measure Information:
Title
Change from baseline in QOL - index
Title
Change from baseline in maximum urinary flow rate, %
Title
Change from baseline in Prostate volume
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with benign prostatic hyperplasia
Exclusion Criteria:
Patients who are suspected to be suffering from prostatic cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)
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