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A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652301
First Posted: April 3, 2008
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
To determine the effect of ezetimibe and simvastatin given together, and ezetimibe and simvastatin given alone on intestinal cholesterol absorption.

Condition Intervention Phase
Cholesterol Drug: ezetimibe Drug: Comparator: Placebo (unspecified) Drug: simvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone. [ Time Frame: Based on 7 week treatment periods. ]

Secondary Outcome Measures:
  • To determine the effects of ezetimibe alone and simvastatin alone on intestinal cholesterol absorption. [ Time Frame: Based on 7 week treatment periods. ]

Enrollment: 40
Study Start Date: July 2003
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ezetimibe 10 mg tablet plus simvastatin 20 mg tablet
Drug: ezetimibe
ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks.
Other Name: MK0653
Drug: simvastatin
simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
Other Name: MK0733
Active Comparator: 2
ezetimibe 10 mg tablet
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.
Active Comparator: 3
simvastatin 20 mg tablet
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
Placebo Comparator: 4
matching placebo
Drug: Comparator: Placebo (unspecified)
matching placebo tablet. Duration of Treatment 31 Weeks.

Detailed Description:
Patients will be randomized into 1 of 4 treatment sequences involving 4 consecutive 7-week treatment periods.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652301


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Schering-Plough
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00652301     History of Changes
Other Study ID Numbers: 0653-050
MK0653-050
2007_559
First Submitted: March 31, 2008
First Posted: April 3, 2008
Last Update Posted: March 10, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors