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Completed

NCT Number: NCT00092716

Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)

The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.

Completed

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 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

  • Elevated cholesterol levels

Exclusion criteria

  • Liver disease
  • Unstable medical conditions

Treatment and study plan

MK0653, ezetimibe / Duration of Treatment: 28 weeks

Drug

Comparator: atorvastatin / Duration of Treatment: 28 weeks

Drug

Primary outcomes

  1. To evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.

Secondary outcomes

  1. Assess safety/tolerability and evaluate effect on HDL-C & on reduction of LDL-C

  2. Evaluate % of pts who attain their NCEP-ATP III goal for LDL-C @ each dose level

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel Group, 28-Week Study to Evaluate the Efficacy and Safety of Ezetimibe and Simvastatin Co-administration Versus Atorvastatin in Patients With Hypercholesteremia

Important dates

Study start
2002
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.

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