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%

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Atorvastatin

• Study Type: Interventional
• Enrollment (Anticipated): 940
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Rosuvastatin	Drug: Rosuvastatin; Other Names: Crestor
Active Comparator: 2; Atorvastatin	Drug: Atorvastatin; Other Names: Lipitor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Russell Esterline, AstraZeneca; Principal Investigator: Prof. Anton Stalenhoef, University Medical Centre, The Netherlands

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Study Completion (Actual): February 1, 2005

Study Registration Dates

• First Submitted: April 3, 2008
• First Submitted That Met QC Criteria: April 3, 2008
• First Posted (Estimate): April 8, 2008

Study Record Updates

• Last Update Posted (Estimate): March 16, 2009
• Last Update Submitted That Met QC Criteria: March 13, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Cholesterol; metabolic syndrome; Rosuvastatin; hypercholesterolemia; low density lipoproteins
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: 4522IL/0069; D3560C00069