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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00090168
• Collaborator: (none)
• Enrollment: 435
• Actual Duration (Months): 9.5

Study Details

Study Description

Brief Summary

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 435 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (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
• Actual Study Start Date: Jan 27, 2004
• Actual Primary Completion Date: Oct 20, 2004
• Actual Study Completion Date: Nov 10, 2004

Outcome Measures

Primary Outcome Measures

1. LDL-C lowering []

Secondary Outcome Measures

1. Total cholesterol (TC) lowering []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme Corp.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Barrios V, Amabile N, Paganelli F, Chen JW, Allen C, Johnson-Levonas AO, Massaad R, Vandormael K. Lipid-altering efficacy of switching from atorvastatin 10 mg/day to ezetimibe/simvastatin 10/20 mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease. Int J Clin Pract. 2005 Dec;59(12):1377-86.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00090168
• Other Study ID Numbers: 0653A-806; 2004_002
• First Posted: Aug 27, 2004
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Vascular Diseases; Coronary Disease; Hypercholesterolemia; Atorvastatin; Simvastatin; Ezetimibe

Study Results

No Results Posted as of Feb 15, 2022