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Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: rofecoxib (Drug); Comparator: placebo (unspecified) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

To determine the efficacy and safety of an investigational compound (MK0966) for the prevention of prostate cancer.

Clinical Details

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Rofecoxib in Decreasing the Risk of Prostate Cancer (ViP Study)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Time to prostate cancer

Secondary outcome: Time to aggressive prostate cancer

Detailed description: The duration of treatment is 6 years.

Eligibility

Minimum age: 50 Years. Maximum age: 75 Years. Gender(s): Male.

Criteria:

Regular PSA testing and study biopsies required.

Locations and Contacts

Additional Information

Related publications:

van Adelsberg J, Gann P, Ko AT, Damber JE, Logothetis C, Marberger M, Schmitz-Drager BJ, Tubaro A, Harms CJ, Roehrborn C. The VIOXX in Prostate Cancer Prevention study: cardiovascular events observed in the rofecoxib 25 mg and placebo treatment groups. Curr Med Res Opin. 2007 Sep;23(9):2063-70.

Starting date: June 2003
Last updated: May 21, 2014

Page last updated: August 23, 2015

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