Back to resultsCOMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Cholesterol, hypercholesterolemia, low density lipoproteins, metabolic syndrome, Rosuvastatin
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Rosuvastatin
Atorvastatin
Outcomes
Primary Outcome Measures
Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.
Secondary Outcome Measures
Modification of other lipids and lipoproteins
Modification of insulin resistance, inflammatory markers & glucose metabolism
Safety: adverse events & abnormal laboratory markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00654485
Brief Title
COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Cholesterol, hypercholesterolemia, low density lipoproteins, metabolic syndrome, Rosuvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
940 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rosuvastatin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Primary Outcome Measure Information:
Title
Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.
Time Frame
At 6 & 12 weeks
Secondary Outcome Measure Information:
Title
Modification of other lipids and lipoproteins
Time Frame
At 6 & 12 weeks
Title
Modification of insulin resistance, inflammatory markers & glucose metabolism
Time Frame
At 6 & 12 weeks
Title
Safety: adverse events & abnormal laboratory markers
Time Frame
At 6 & 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Anton Stalenhoef
Organizational Affiliation
University Medical Centre, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russell Esterline
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects
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