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Completed

NCT Number: NCT00127179

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

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

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with benign prostatic hyperplasia

Exclusion criteria

  • Patients who are suspected to be suffering from prostatic cancer

Treatment and study plan

MK0906, finasteride / Duration of Treatment: 48 weeks

Drug

Comparator: placebo / Duration of Treatment: 48 weeks

Drug

Primary outcomes

  1. Change from baseline in the International Prostate Symptom Score

Secondary outcomes

  1. Change from baseline in QOL - index

  2. Change from baseline in maximum urinary flow rate, %

  3. Change from baseline in Prostate volume

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Aug 5, 2005
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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