COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome
Intervention: Rosuvastatin (Drug); Atorvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Prof. Anton Stalenhoef, Principal Investigator, Affiliation: University Medical Centre, The Netherlands
Russell Esterline, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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%
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.
Secondary outcome: Modification of other lipids and lipoproteinsModification of insulin resistance, inflammatory markers & glucose metabolism Safety: adverse events & abnormal laboratory markers
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: May 2002
Ending date: May 2005
Last updated: April 3, 2008
|
