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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00239681
First received: October 13, 2005
Last updated: February 6, 2014
Last verified: February 2014
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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 High-sensitivity C-Reactive Protein (hsCRP) |
Drug: Rosuvastatin Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) 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 Low Density Lipoprotein(LDL) Cholesterol & Elevated Levels of C-Reactive Protein |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean
Secondary Outcome Measures:
- Time to Death Due to Any Cause [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean
- Time to Non-cardiovascular Death [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean
- Time to Development of Diabetes Mellitus [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean
- Time to Venous Thromboembolic Event [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean
- Time to Bone Fracture [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean
| Enrollment: | 17802 |
| Study Start Date: | February 2003 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rosuvastatin
Rosuvastatin 20 mg once daily
|
Drug: Rosuvastatin
Oral
Other Name: Crestor
|
|
Placebo Comparator: Placebo
Placebo once daily
|
Other: Placebo
Oral
|
Detailed Description:
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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239681
Show 859 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239681
Show 859 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Judith Hsia, MD | AstraZeneca |
| Study Chair: | Paul Ridker, MD | Brigham and Women's Hospital |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00239681 History of Changes |
| Other Study ID Numbers: | D3560L00030 Jupiter 4522US/0011 |
| Study First Received: | October 13, 2005 |
| Results First Received: | August 20, 2009 |
| Last Updated: | February 6, 2014 |
| 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 Calcium Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on September 29, 2016