JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events

Phase 3

Terminated

• Conditions: Elevated High-sensitivity C-Reactive Protein (hsCRP)
• Interventions: Drug: Rosuvastatin; Other: Placebo

• Registration Number: NCT00239681
• Lead Sponsor: AstraZeneca

Brief Summary

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.

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-08-20
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Results First Posted: 2014-03-24
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17802

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	Rosuvastatin 20 mg once daily
Placebo	Placebo	Placebo once daily

Primary Outcome Measures

Name	Time	Method
Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)	up to 5 years	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

Name	Time	Method
Time to Death Due to Any Cause	up to 5 years	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	up to 5 years	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	up to 5 years	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	up to 5 years	Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean
Time to Bone Fracture	Up to 5 years	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

Trial Locations

Locations (1)

Research Site; 🇻🇪 Punto Fijo, Estado Falcon, Venezuela