Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)
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ClinicalTrials.gov Identifier: NCT00092716 |
Recruitment Status :
Completed
First Posted : September 28, 2004
Last Update Posted : March 1, 2017
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Brief Summary:
The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia | Drug: MK0653, ezetimibe / Duration of Treatment: 28 weeks Drug: Comparator: atorvastatin / Duration of Treatment: 28 weeks | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 655 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia |
Study Start Date : | May 2002 |
Actual Primary Completion Date : | April 2003 |
Actual Study Completion Date : | April 2003 |
Resource links provided by the National Library of Medicine

Primary Outcome Measures :
- To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.
Secondary Outcome Measures :
- Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C
- Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level
Information from the National Library of Medicine

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Elevated cholesterol levels
Exclusion Criteria:
- Liver disease
- Unstable medical conditions
No Contacts or Locations Provided
Publications:
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00092716 |
Other Study ID Numbers: |
0653-025 2004_047 |
First Posted: | September 28, 2004 Key Record Dates |
Last Update Posted: | March 1, 2017 |
Last Verified: | February 2017 |
Additional relevant MeSH terms:
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Ezetimibe |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |