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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00239681 |
The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.
Condition | Intervention | Phase |
---|---|---|
Elevated hs C-Reactive Protein |
Drug: Rosuvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study of Rosuvastatin (CRESTOR®) 20 mg in the Prevention of Cardiovascular Events Among Subjects With Low Levels of LDL Cholesterol & Elevated Levels of C-Reactive Protein |
Estimated Enrollment: | 15000 |
Study Start Date: | February 2003 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Judith Hsia, MD | AstraZeneca |
Study Chair: | Paul Ridker, MD | Brigham and Women's Hospital |
Responsible Party: | AstraZeneca ( Michael Cressman / Medical Science Director ) |
Study ID Numbers: | D3560L00030, Jupiter, 4522US/0011 |
Study First Received: | October 13, 2005 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00239681 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Primary prevention Cardiovascular disease Statin therapy C-reactive protein |
Antimetabolites Rosuvastatin Antilipemic Agents Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Antimetabolites Rosuvastatin Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |