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| Tracking Information | |||||
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| First Received Date ICMJE | May 6, 2003 | ||||
| Last Updated Date | November 2, 2009 | ||||
| Start Date ICMJE | June 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Time to prostate cancer [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Time to prostate cancer | ||||
| Change History | Complete list of historical versions of study NCT00060476 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Time to aggressive prostate cancer [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Time to aggressive prostate cancer | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment With MK0966 for the Prevention of Prostate Cancer | ||||
| Official Title ICMJE | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Rofecoxib in Decreasing the Risk of Prostate Cancer (ViP Study) | ||||
| Brief Summary | To determine the efficacy and safety of an investigational compound (MK0966) for the prevention of prostate cancer. |
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| Detailed Description | The duration of treatment is 6 years. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 15000 | ||||
| Completion Date | February 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Regular PSA testing and study biopsies required. |
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| Gender | Male | ||||
| Ages | 50 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00060476 | ||||
| Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
| Study ID Numbers ICMJE | 2006_414, Formally-P30A03LD, MK0966-201 | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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