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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014