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

Tracking Information

First Received Date ^ICMJE

October 13, 2005

Last Updated Date

February 3, 2009

Start Date ^ICMJE

February 2003

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00239681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

- 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.

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

Elevated hs C-Reactive Protein

Intervention ^ICMJE

Drug: Rosuvastatin

Other Name: Crestor

Study Arms

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

15000

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Denmark, El Salvador, Estonia, Germany, Israel, Mexico, Netherlands, Norway, Panama, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Switzerland, United Kingdom, Uruguay, Venezuela

Administrative Information

NCT Number ^ICMJE

NCT00239681

Other Study ID Numbers ^ICMJE

D3560L00030, Jupiter, 4522US/0011

Has Data Monitoring Committee

Yes

Responsible Party

Michael Cressman / Medical Science Director, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Judith Hsia, MD	AstraZeneca
Study Chair:	Paul Ridker, MD	Brigham and Women's Hospital

Information Provided By

AstraZeneca

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP