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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00239681

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 III

Drug Information available for: Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

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

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)

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

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

Publications indexed to this study:

Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov 20;359(21):2195-207. Epub 2008 Nov 9.

Responsible Party:	AstraZeneca ( Michael Cressman / Medical Science Director )
Study ID Numbers:	D3560L00030, Jupiter, 4522US/0011
Study First Received:	October 13, 2005
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00239681
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Primary prevention
Cardiovascular disease
Statin therapy
C-reactive protein

Study placed in the following topic categories:

Rosuvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009