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

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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)

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
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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Ridker PM, MacFadyen JG, Fonseca FA, Genest J, Gotto AM, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Number needed to treat with rosuvastatin to prevent first cardiovascular events and death among men and women with low low-density lipoprotein cholesterol and elevated high-sensitivity C-reactive protein: justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin (JUPITER). Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):616-23. Epub 2009 Sep 22.

Everett BM, Glynn RJ, MacFadyen JG, Ridker PM. Rosuvastatin in the prevention of stroke among men and women with elevated levels of C-reactive protein: justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER). Circulation. 2010 Jan 5;121(1):143-50. Epub 2009 Dec 21.

Glynn RJ, 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, Ridker PM. A randomized trial of rosuvastatin in the prevention of venous thromboembolism. N Engl J Med. 2009 Apr 30;360(18):1851-61. Epub 2009 Mar 29.

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 Trial Study Group. Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet. 2009 Apr 4;373(9670):1175-82. Epub 2009 Mar 28.

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:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00239681 History of Changes
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:

Antimetabolites
Rosuvastatin
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 February 08, 2010