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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Metabolic Syndrome

Treatments: Drug: Atorvastatin; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654485

4522IL/0069

D3560C00069

Details and patient eligibility

About

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.

Enrollment: 940 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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940 participants in 2 patient groups

1

Experimental group

Description:

Rosuvastatin

Treatment:

Drug: Rosuvastatin

2

Active Comparator group

Description:

Atorvastatin

Treatment:

Drug: Atorvastatin