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

Sponsors and Collaborators:	Merck Schering-Plough
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00652301

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 III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
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

Drug Information available for: Simvastatin Ezetimibe

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
1: Experimental ezetimibe 10 mg tablet plus simvastatin 20 mg tablet	Drug: ezetimibe ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks. Drug: simvastatin simvastatin 20 mg tablet. Duration of Treatment 31 Weeks.
2: Active Comparator ezetimibe 10 mg tablet	Drug: ezetimibe ezetimibe 10 mg tablet. Duration of Treatment 31 Weeks. Drug: Comparator: Placebo (unspecified) matching placebo tablet. Duration of Treatment 31 Weeks.
3: Active Comparator 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.
4: Placebo Comparator 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

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:

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:

Antimetabolites
Simvastatin
Antilipemic Agents

Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Simvastatin
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009