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

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%

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654485

Enrollment

940

Registered

2008-04-08

Start date

2002-05-31

Completion date

2005-02-28

Last updated

2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Cholesterol, hypercholesterolemia, low density lipoproteins, metabolic syndrome, Rosuvastatin

Brief 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.

Interventions

DRUGRosuvastatin

DRUGAtorvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.	At 6 & 12 weeks

Secondary

Measure	Time frame
Modification of other lipids and lipoproteins	At 6 & 12 weeks
Modification of insulin resistance, inflammatory markers & glucose metabolism	At 6 & 12 weeks
Safety: adverse events & abnormal laboratory markers	At 6 & 12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026