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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00654485
First received: April 3, 2008
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  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 3

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:

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 May 19, 2013