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

Intervention Details:

Other Name: Crestor

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 ClinicalTrials.gov Identifier (NCT Number):

Dorresteijn JA, Visseren FL, Ridker PM, Wassink AM, Paynter NP, Steyerberg EW, van der Graaf Y, Cook NR. Estimating treatment effects for individual patients based on the results of randomised clinical trials. BMJ. 2011 Oct 3;343:d5888.

Albert MA, Glynn RJ, Fonseca FA, Lorenzatti AJ, Ferdinand KC, MacFadyen JG, Ridker PM. Race, ethnicity, and the efficacy of rosuvastatin in primary prevention: the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial. Am Heart J. 2011 Jul;162(1):106-14.e2. Epub 2011 Jun 12.

Ridker PM, MacFadyen JG, Glynn RJ, Chasman DI. Kinesin-like protein 6 (KIF6) polymorphism and the efficacy of rosuvastatin in primary prevention. Circ Cardiovasc Genet. 2011 Jun;4(3):312-7. Epub 2011 Apr 14.

Koenig W, Ridker PM. Rosuvastatin for primary prevention in patients with European systematic coronary risk evaluation risk ? 5% or Framingham risk >20%: post hoc analyses of the JUPITER trial requested by European health authorities. Eur Heart J. 2011 Jan;32(1):75-83. Epub 2010 Oct 22.

Ridker PM, Macfadyen JG, Nordestgaard BG, Koenig W, Kastelein JJ, Genest J, Glynn RJ. Rosuvastatin for primary prevention among individuals with elevated high-sensitivity c-reactive protein and 5% to 10% and 10% to 20% 10-year risk. Implications of the Justification for Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial for "intermediate risk". Circ Cardiovasc Qual Outcomes. 2010 Sep 1;3(5):447-52. Epub 2010 Aug 24.

Ridker PM, Genest J, Boekholdt SM, Libby P, Gotto AM, Nordestgaard BG, Mora S, MacFadyen JG, Glynn RJ, Kastelein JJ; JUPITER Trial Study Group. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial. Lancet. 2010 Jul 31;376(9738):333-9. Epub 2010 Jul 23.

Ridker PM, MacFadyen J, Cressman M, Glynn RJ. Efficacy of rosuvastatin among men and women with moderate chronic kidney disease and elevated high-sensitivity C-reactive protein: a secondary analysis from the JUPITER (Justification for the Use of Statins in Prevention-an Intervention Trial Evaluating Rosuvastatin) trial. J Am Coll Cardiol. 2010 Mar 23;55(12):1266-73. Epub 2010 Mar 4.

Mora S, Glynn RJ, Hsia J, MacFadyen JG, Genest J, Ridker PM. Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia: results from the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and meta-analysis of women from primary prevention trials. Circulation. 2010 Mar 9;121(9):1069-77. Epub 2010 Feb 22.

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:	Michael Cressman / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00239681 History of Changes
Other Study ID Numbers:	D3560L00030, Jupiter, 4522US/0011
Study First Received:	October 13, 2005
Last Updated:	February 3, 2009
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:

Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012