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NCT00092716 Clinical Trial

Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092716
Other study ID # 0653-025
Secondary ID 2004_047
Status Completed
Phase Phase 3
First received
Last updated
Start date May 2002
Est. completion date April 2003

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

The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.

Recruitment information / eligibility
Status Completed
Enrollment 655
Est. completion date April 2003
Est. primary completion date April 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility Inclusion Criteria: - Elevated cholesterol levels Exclusion Criteria: - Liver disease - Unstable medical conditions

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0653, ezetimibe / Duration of Treatment: 28 weeks

• Comparator: atorvastatin / Duration of Treatment: 28 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (3)

Ballantyne CM, Blazing MA, King TR, Brady WE, Palmisano J. Efficacy and safety of ezetimibe co-administered with simvastatin compared with atorvastatin in adults with hypercholesterolemia. Am J Cardiol. 2004 Jun 15;93(12):1487-94. — View Citation

Catapano A, Brady WE, King TR, Palmisano J. Lipid altering-efficacy of ezetimibe co-administered with simvastatin compared with rosuvastatin: a meta-analysis of pooled data from 14 clinical trials. Curr Med Res Opin. 2005 Jul;21(7):1123-30. — View Citation

McKenney J, Ballantyne CM, Feldman TA, Brady WE, Shah A, Davies MJ, Palmisano J, Mitchel YB. LDL-C goal attainment with ezetimibe plus simvastatin coadministration vs atorvastatin or simvastatin monotherapy in patients at high risk of CHD. MedGenMed. 2005 Jul 14;7(3):3. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.
Secondary Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C
Secondary Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level
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