CRESTOR Athero Imaging Head to Head IVUS Study - SATURN
Study identifier:D356IC00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2007-004000-13
CTIS identifier:N/A
Study Complete
Official Title
Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)
Medical condition
Coronary atherosclerosis
Phase
Phase 3
Healthy volunteers
No
Study drug
Rosuvastatin, Atorvastatin
Sex
All
Actual Enrollment
2333
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Jan 2008
Primary Completion Date: 01 Jun 2011
Study Completion Date: 01 Jun 2011
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
The Cleveland Clinic
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rosuvastatin 20 mg Rosuvastatin 20 mg distributed in 2-week run-in period | Drug: Rosuvastatin capsule, oral, once daily Other Name: Crestor |
| Active Comparator: Atorvastatin 40 mg Atorvastatin 40 mg distributed in 2-week run-in period | Drug: Atorvastatin capsule, oral, one daily Other Name: Lipitor |
| Experimental: Rosuvastatin 40 mg Rosuvastatin 40 mg distributed in core 2-year study | Drug: Rosuvastatin capsule, oral, once daily Other Name: Crestor |
| Active Comparator: Atorvastatin 80 mg Atorvastatin 80 mg distributed in core 2-year study | Drug: Atorvastatin capsule, oral, one daily Other Name: Lipitor |
Contacts
Investigators
Principal Investigator
Stephen J Nicholls
Cleveland Clinic Foundation, Cardiovascular Medicine
