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Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092716
First received: September 23, 2004
Last updated: February 28, 2017
Last verified: February 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: MK0653, ezetimibe / Duration of Treatment: 28 weeks Drug: Comparator: atorvastatin / Duration of Treatment: 28 weeks | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (masked roles unspecified) 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cholesterol
Drug Information available for:
Atorvastatin
Atorvastatin calcium
Ezetimibe
Atorvastatin calcium trihydrate
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
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
| Enrollment: | 655 |
| Study Start Date: | May 2002 |
| Study Completion Date: | April 2003 |
| Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Elevated cholesterol levels
Exclusion Criteria:
- Liver disease
- Unstable medical conditions
Contacts and Locations
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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.
No Contacts or Locations Provided
No Contacts or Locations Provided
More Information
Publications:
Study Data/Documents: CSR Synopsis
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00092716 History of Changes |
| Other Study ID Numbers: |
0653-025 2004_047 |
| Study First Received: | September 23, 2004 |
| Last Updated: | February 28, 2017 |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Calcium Ezetimibe |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on July 21, 2017