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A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00652301
First received: March 31, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 31, 2008
March 31, 2008
July 2003
April 2004   (final data collection date for primary outcome measure)
reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone. [ Time Frame: Based on 7 week treatment periods. ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption. [ Time Frame: Based on 7 week treatment periods. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol
A Randomized, Double-Blind, Placebo-Controlled,4-Period, Crossover Study to Evaluate the Effects of Ezetimibe and Simvastatin, Coadministered and Alone, on Intestinal Absorption of Cholesterol

To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.

Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Cholesterol
  • Drug: ezetimibe
    ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.
    Other Name: MK0653
  • Drug: Comparator: Placebo (unspecified)
    matching placebo tablet. Duration of Treatment 31 Weeks.
  • Drug: simvastatin
    simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
    Other Name: MK0733
  • Experimental: 1
    ezetimibe 10 mg tablet plus simvastatin 20 mg tablet
    Interventions:
    • Drug: ezetimibe
    • Drug: simvastatin
  • Active Comparator: 2
    ezetimibe 10 mg tablet
    Interventions:
    • Drug: ezetimibe
    • Drug: Comparator: Placebo (unspecified)
  • Active Comparator: 3
    simvastatin 20 mg tablet
    Interventions:
    • Drug: Comparator: Placebo (unspecified)
    • Drug: simvastatin
  • Placebo Comparator: 4
    matching placebo
    Intervention: Drug: Comparator: Placebo (unspecified)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Not Provided
April 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males between the ages of 18-55 with LDL More than 130, but less than 180

Exclusion Criteria:

  • Individuals with drug or substance abuse
  • Individuals with poor mental function
  • Individuals having more than 14 alcoholic drinks a week
  • Individuals that have been treated with any other investigational drug in the last 30 days
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00652301
2007_559, MK0653-050
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Schering-Plough
Study Director: Medical Monitor Merck
Merck
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP