COMETS - compare the efficacy of Rosuvastatin with Atorvastatin and placebo in the treatment of non-diabetic, non-atheroscleric, metabolic syndrome subjects
Study identifier:4522IL/0069
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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%
Medical condition
Metabolic Syndrome
Phase
Phase 3
Healthy volunteers
No
Study drug
Rosuvastatin, Atorvastatin
Sex
All
Actual Enrollment
940
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 May 2002
Primary Completion Date: -
Study Completion Date: 01 Feb 2005
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Rosuvastatin | - |
| Active Comparator: 2 Atorvastatin | - |
Contacts
Investigators
Principal Investigator
Prof. Anton Stalenhoef
University Medical Centre, The Netherlands
