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OpenTrials
Completed

NCT Number: NCT00654485

COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects

The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.

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Key information

Conditions

Metabolic Syndrome Dyslipidemias Glucose Metabolism Disorders Hypercholesterolemia Hyperinsulinism Hyperlipidemias Insulin Resistance 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of 3 or more coronary heart disease risk factors as defined by the protocol.
  • Fasting low density lipoprotein cholesterol level of > 130 mg/dL.
  • Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
  • Not previously taken statins.

Exclusion criteria

  • The use of lipid lowering drugs or dietary supplements after Visit 1
  • Active arterial disease eg Unstable angina, or recent arterial surgery
  • Blood lipid levels above the limits defined in the protocol
  • Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Treatment and study plan

Rosuvastatin

Drug

Other names: Crestor

atorvastatin

Drug

Other names: Lipitor

Primary outcomes

  1. Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.

    Time frame: At 6 & 12 weeks

Secondary outcomes

  1. Modification of other lipids and lipoproteins

    Time frame: At 6 & 12 weeks

  2. Modification of insulin resistance, inflammatory markers & glucose metabolism

    Time frame: At 6 & 12 weeks

  3. Safety: adverse events & abnormal laboratory markers

    Time frame: At 6 & 12 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With Raised LDL-C and a 10 Year Risk of CHD >10%

Important dates

Study start
2002
Study completion
2005
First posted
Apr 8, 2008
Registry last updated
Mar 16, 2009

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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