An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)

The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

Completed

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic 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

High cholesterol

Exclusion criteria

Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Treatment and study plan

MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeks

Drug

Primary outcomes

Plasma LDL-C.

Secondary outcomes

Plasma TG and HDL-C; proportion of patients achieving LDL-C targets; tolerability.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Sep 28, 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