A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)

Coronary Disease Clinical Trial

Official title:

A Comparison of Treatment With Ezetimibe (SCH 58235) and Simvastatin Coadministration Versus Simvastatin in Attaining the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Coronary Heart Disease (CHD) or CHD Risk Equivalent Strata Low-Density Lipoprotein Cholesterol (LDL-c)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551447
• Other study ID #: 0653-023
• Secondary ID: MK0653-0232006_5
• Status: Completed
• Phase: Phase 3
• Start date: January 2002
• Est. completion date: March 2003

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This purpose of this study is to determine if the administration of ezetimibe and simvastatin together is more effective than simvastatin alone in lowering LDL-C levels to a goal of <100 mg/dL in patients at risk for Heart Disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 616
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men and women aged 18 to 80 at risk for Heart Disease who have LDL-C levels greater than or equal to 130 mg/dL and triglyceride level less than or equal to 350 mg/dL

• Patients must be able to maintain the National Cholesterol Education Program diet throughout the course of the study

Exclusion Criteria:

• Patients are excluded from the study if their weight is less than 50% of ideal body weight, if they are pregnant or lactating, have congestive heart failure, uncontrolled heart rhythm problems or a recent heart attack, coronary artery bypass surgery, or angioplasty. Additionally, patients with poorly controlled Type 1 or 2 diabetes mellitus, kidney disease, uncontrolled endocrine or metabolic disease, are known HIV positive, and uncontrolled high blood pressure

Related Conditions & MeSH terms

• Coronary Disease
• Heart Diseases

Intervention

Drug:
• MK0653, ezetimibe / Duration of Treatment: 27 Weeks

• MK0733, simvastatin / Duration of Treatment: 27 Weeks

• Comparator: simvastatin / Duration of Treatment: 27 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (3)

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

Feldman T, Koren M, Insull W Jr, McKenney J, Schrott H, Lewin A, Shah S, Sidisin M, Cho M, Kush D, Mitchel Y. Treatment of high-risk patients with ezetimibe plus simvastatin co-administration versus simvastatin alone to attain National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals. Am J Cardiol. 2004 Jun 15;93(12):1481-6. — 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	LDL-C measurement (target goal = <100 mg/dL)		27 Weeks
Secondary	Well tolerated in patients		27 Weeks