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OpenTrials
Completed

NCT Number: NCT00092586

Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)

The purpose of this 6-week study is to compare the reduction in specific levels of cholesterol in patients with high cholesterol.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic 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 6 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • High cholesterol levels that are identified by specific laboratory values

Exclusion criteria

  • Active liver disease
  • Any condition or situation which would interfere with participation

Treatment and study plan

MK0653, ezetimibe

Drug

Comparator: statins

Drug

Primary outcomes

  1. Percent change in LDL-C

Secondary outcomes

  1. Percentage of patients reaching NCEP ATP III target LDL-C levels

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multi-center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg/Day When Added to Ongoing Therapy With a Statin Versus Statin Therapy Alone, in Patients With Hypercholesterolemia Who Have Not Reached National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Target LDL-Cholesterol Level

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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