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Completed

NCT Number: NCT00090298

Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Drugs in Patients With Elevated Cholesterol Levels (0653A-058)

A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.

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Key information

Conditions

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

Age range

18 year–69 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.

Men and women aged 18 to 69 years, with elevated cholesterol levels may be eligible to participate in a research study to assess the efficacy and safety of two marketed drugs.

Treatment and study plan

MK0653A, ezetimibe (+) simvastatin

Drug

Comparator: Rosuvastatin

Drug

Primary outcomes

  1. LDL-C lowering efficacy after 6 weeks.

Secondary outcomes

  1. Safety;changes in TC, non-HDL-C, TG, HDL-C, Apo B, LDL-C/HCL-C ratio.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind Study to Evaluate the Lipid-Altering Efficacy and Safety of the Ezetimibe/Simvastatin Combination Tablet Versus Rosuvastatin in Patients With Primary Hypercholesterolemia

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Aug 30, 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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