Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)

This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.

Completed

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Key information

Conditions

Hypercholesterolemia Cardiovascular Diseases Coronary Disease Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The duration of treatment is 10 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with elevated cholesterol and coronary heart disease

Exclusion criteria

Patients who do not meet specific cholesterol levels as required by the study

Treatment and study plan

MK0653, ezetimibe

Drug

Comparator: ezetimibe, placebo

Drug

Primary outcomes

Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment

Secondary outcomes

Safety and tolerability.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Sep 27, 2004
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.

Published trials that share one or more normalized conditions with this study.

Completed