- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00551447
A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)
February 7, 2022 updated by: Organon and Co
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)
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
616
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
LDL-C measurement (target goal = <100 mg/dL)
Time Frame: 27 Weeks
|
27 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Well tolerated in patients
Time Frame: 27 Weeks
|
27 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/j.amjcard.2004.02.059.
- 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. doi: 10.1185/030079905X50642.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (Actual)
March 1, 2003
Study Completion (Actual)
March 1, 2003
Study Registration Dates
First Submitted
October 29, 2007
First Submitted That Met QC Criteria
October 29, 2007
First Posted (Estimate)
October 31, 2007
Study Record Updates
Last Update Posted (Actual)
February 18, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Cardiovascular Diseases
- Vascular Diseases
- Heart Diseases
- Coronary Disease
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
- Ezetimibe
Other Study ID Numbers
- 0653-023
- MK0653-023
- 2006_555
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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