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OpenTrials
Completed

NCT Number: NCT00092690

MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)

This study is to assess the safety and efficacy of an investigational drug as compared to an approved drug to reduce specific cholesterol levels.

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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

About this study

The duration of treatment is 6 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elevated cholesterol

Exclusion criteria

  • Unstable medical conditions or significant heart problems within 3 months prior to first study visit.

Treatment and study plan

MK0653A, ezetimibe (+) simvastatin

Drug

Comparator: atorvastatin

Drug

Primary outcomes

  1. Plasma LDL-C averaged across all doses after 6 weeks

Secondary outcomes

  1. Plasma LDL-C for each dose; plasma HDL-C averaged across all doses

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Hypercholesterolemia

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 28, 2004
Registry last updated
May 10, 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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