A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Disease
Intervention: MK0653, ezetimibe / Duration of Treatment: 27 Weeks (Drug); MK0733, simvastatin / Duration of Treatment: 27 Weeks (Drug); Comparator: simvastatin / Duration of Treatment: 27 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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)
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: LDL-C measurement (target goal = <100 mg/dL)
Secondary outcome: Well tolerated in patients
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Related publications: 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. 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. 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.
Starting date: January 2002
Last updated: January 11, 2008
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