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”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin

Primary Measures

• Investigate whether long-term treatment with rosuvastatin compared with placebo will decrease the rate of major cardiovascular events

Secondary 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.

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)(> 2.0mg/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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Judith Hsia, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00239681

Study ID Number: D3560L00030

ClinicalTrials.gov Identifier: NCT00239681

Health Authority: United States: Food and Drug Administration