Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
AstraZeneca The Cleveland Clinic |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00620542 |
A 104-week, randomized, double-blink, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.
Condition | Intervention | Phase |
---|---|---|
Coronary Atherosclerosis |
Drug: Rosuvastatin Drug: Atorvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN) |
Estimated Enrollment: | 1300 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Rosuvastatin
capsule, oral, once daily
|
2: Active Comparator |
Drug: Atorvastatin
capsule, oral, one daily
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
Principal Investigator: | Stephen J Nicholls, MBBS, PhD | Cleveland Clinic Foundation, Cardiovascular Medicine |
Responsible Party: | AstraZeneca Pharmaceuticals ( Michael Cressman, Executive Medical Director ) |
Study ID Numbers: | D356IC00001, 2007-004000-13 |
Study First Received: | February 6, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00620542 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Belgium: Ministry of Health; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Mexico: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Poland: Office for Registration of Medicinal Products, Medical Devies and Biogical Products; Spain: Spanish Agency of Medicines; United States: Food and Drug Administration |
Coronary artery disease |
Arterial Occlusive Diseases Coronary Disease Atherosclerosis Rosuvastatin Heart Diseases Myocardial Ischemia |
Vascular Diseases Ischemia Arteriosclerosis Atorvastatin Coronary Artery Disease |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |