JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events
This study has been terminated.
(See detailed description for reason.)
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00239681
First received: October 13, 2005
Last updated: February 3, 2009
Last verified: February 2009
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Investigate whether long-term treatment with rosuvastatin compared with placebo will decrease the rate of major cardiovascular events
Secondary Outcome Measures:
- Investigate the safety of long-term treatment with rosuvastatin compared with placebo through comparisons of total mortality, noncardiovascular mortality, & adverse events
- Investigate whether therapy with rosuvastatin reduces the incidence of diabetes mellitus, venous thromboembolic events, & the incidence of bone fractures.
| 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) |
Intervention Details:
Detailed Description:
-
Drug: Rosuvastatin
Other Name: Crestor
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men 50 years or older, women 60 years or older
- Low to normal levels of low density lipoprotein (LDL) cholesterol (< 130mg/dL)
- Elevated levels of C-Reactive Protein (CRP) > 2.0 mg/L
Exclusion Criteria:
- History of cardiovascular or cerebrovascular events
- Active liver disease
- Diabetes mellitus
- Uncontrolled hypertension or hypothyroidism
- History of certain malignancies
- Chronic inflammatory conditions
- History of alcohol or drug abuse
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239681
Show 859 Study Locations
Show 859 Study LocationsSponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Judith Hsia, MD | AstraZeneca |
| Study Chair: | Paul Ridker, MD | Brigham and Women's Hospital |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael Cressman / Medical Science Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00239681 History of Changes |
| Other Study ID Numbers: | D3560L00030, Jupiter, 4522US/0011 |
| Study First Received: | October 13, 2005 |
| Last Updated: | February 3, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Primary prevention Cardiovascular disease Statin therapy C-reactive protein |
Additional relevant MeSH terms:
|
Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013