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:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00652301
First received: March 31, 2008
Last updated: May 2, 2014
Last verified: May 2014
  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:


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. ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652301

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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00652301     History of Changes
Other Study ID Numbers: 0653-050, MK0653-050, 2007_559
Study First Received: March 31, 2008
Last Updated: May 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 28, 2014