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Cholesterol Lowering Level of MK0653A+Simvastatin in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease (0653A-806)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090168
First received: August 25, 2004
Last updated: April 5, 2017
Last verified: April 2017
  Purpose
A 6-week treatment study to compare the reduction in cholesterol of two drugs MK0653A+Simvastatin for high cholesterol, in patients with hypercholesterolemia and atherosclerotic or coronary vascular disease.

Condition Intervention Phase
Hypercholesterolemia Atherosclerotic Disease Coronary Disease Drug: MK0653A , ezetimibe (+) simvastatin Drug: Comparator: atorvastatin Drug: Duration of Treatment: 6 weeks Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Multicenter Study to Assess the Cholesterol Lowering Level of Switching to an Investigational Drug Compared to Doubling the Dose of an Investigational Drug in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • LDL-C lowering

Secondary Outcome Measures:
  • Total cholesterol (TC) lowering

Enrollment: 435
Actual Study Start Date: January 27, 2004
Study Completion Date: November 10, 2004
Primary Completion Date: October 20, 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
- Men and women greater than or equal to 18 years of age with elevated cholesterol levels and coronary heart disease (CHD), or atherosclerotic vascular disease may be eligible to participate in this study.
  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: NCT00090168

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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00090168     History of Changes
Other Study ID Numbers: 0653A-806
2004_002
Study First Received: August 25, 2004
Last Updated: April 5, 2017

Additional relevant MeSH terms:
Hypercholesterolemia
Vascular Diseases
Coronary Disease
Coronary Artery Disease
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Atorvastatin Calcium
Simvastatin
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