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

Last updated: March 13, 2009
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Metabolic Syndrome

High Cholesterol (Hyperlipidemia)

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT00654485
4522IL/0069
D3560C00069
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 establishedatherosclerotic disease.

  • Not previously taken statins.

Exclusion

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

Study Design

Total Participants: 940
Study Start date:
May 01, 2002
Estimated Completion Date:
February 28, 2005