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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00654485

Purpose

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.

Condition	Intervention	Phase
Metabolic Syndrome	Drug: Rosuvastatin Drug: Atorvastatin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official 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%

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Diabetes Medicines Metabolic Syndrome

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	940
Study Start Date:	May 2002
Study Completion Date:	February 2005

Arms	Assigned Interventions
Experimental: 1 Rosuvastatin	Drug: Rosuvastatin Other Name: Crestor
Active Comparator: 2 Atorvastatin	Drug: Atorvastatin Other Name: Lipitor

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654485

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00654485 History of Changes
Other Study ID Numbers:	4522IL/0069, D3560C00069
Study First Received:	April 3, 2008
Last Updated:	March 13, 2009
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Finland: Finnish Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Slovakia: State Institute for Drug Control; United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Cholesterol
hypercholesterolemia
low density lipoproteins
metabolic syndrome
Rosuvastatin

Additional relevant MeSH terms:

Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012