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NCT00090168 Clinical Trial

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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00090168
Other study ID # 0653A-806
Secondary ID 2004_002
Status Completed
Phase Phase 3
First received
Last updated
Start date January 27, 2004
Est. completion date November 10, 2004

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 435
Est. completion date November 10, 2004
Est. primary completion date October 20, 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0653A , ezetimibe (+) simvastatin

• Comparator: atorvastatin

• Duration of Treatment: 6 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary LDL-C lowering
Secondary Total cholesterol (TC) lowering
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