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NCT00092690 Clinical Trial

MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)

Hypercholesterolemia Clinical Trial

Official title:
A Multicenter, Double-Blind, Randomized, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092690
Other study ID # 0653A-051
Secondary ID 2004_051
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2003
Est. completion date March 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

This study is to assess the safety and efficacy of an investigational drug as compared to an approved drug to reduce specific cholesterol levels.

Description:

The duration of treatment is 6 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 1902
Est. completion date March 2004
Est. primary completion date March 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility Inclusion Criteria: - Elevated cholesterol Exclusion Criteria: - Unstable medical conditions or significant heart problems within 3 months prior to first study visit.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0653A, ezetimibe (+) simvastatin

• Comparator: atorvastatin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (2)

Ballantyne CM, Abate N, Yuan Z, King TR, Palmisano J. Dose-comparison study of the combination of ezetimibe and simvastatin (Vytorin) versus atorvastatin in patients with hypercholesterolemia: the Vytorin Versus Atorvastatin (VYVA) study. Am Heart J. 2005 Mar;149(3):464-73. doi: 10.1016/j.ahj.2004.11.023. Erratum In: Am Heart J. 2005 May;149(5):882. — View Citation

Pearson T, Ballantyne C, Sisk C, Shah A, Veltri E, Maccubbin D. Comparison of effects of ezetimibe/simvastatin versus simvastatin versus atorvastatin in reducing C-reactive protein and low-density lipoprotein cholesterol levels. Am J Cardiol. 2007 Jun 15;99(12):1706-1713. doi: 10.1016/j.amjcard.2007.01.062. Epub 2007 May 2. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma LDL-C averaged across all doses after 6 weeks
Secondary Plasma LDL-C for each dose; plasma HDL-C averaged across all doses
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