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Completed

NCT Number: NCT00551447

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

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0653, ezetimibe / Duration of Treatment: 27 Weeks

Drug

MK0733, simvastatin / Duration of Treatment: 27 Weeks

Drug

Comparator: simvastatin / Duration of Treatment: 27 Weeks

Drug

Primary outcomes

  1. LDL-C measurement (target goal = <100 mg/dL)

    Time frame: 27 Weeks

Secondary outcomes

  1. Well tolerated in patients

    Time frame: 27 Weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 31, 2007
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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