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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • reduced intestinal cholesterol absorption with ezetimibe + simvastatin vs simvastatin alone. [ Time Frame: Based on 7 week treatment periods. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2003
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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652301

Sponsors and Collaborators
Merck
Schering-Plough
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00652301     History of Changes
Other Study ID Numbers: 2007_559, MK0653-050
Study First Received: March 31, 2008
Last Updated: March 31, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on June 17, 2013