IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome:Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (Study P04103) - Tabular View

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IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome:Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (Study P04103)

This study is currently recruiting participants.
Information provided by Schering-Plough

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome:Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (Study P04103)
Official Title ^†	A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial - IMPROVE IT)
Brief Summary	This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. If LDL-C response is inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, as appropriate, may be increased to 80 mg. Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of CV death, major coronary events, and stroke.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†	To measure the effect of treatment with ezetimibe/simvastatin compared with simvastatin monotherapy on death due to any cardiovascular events, non-fatal coronary events (such as heart attack), and non-fatal strokes [ Time Frame: Trial will continue until a minimum of 5,250 subjects have a primary endpoint event and each subject is followed for a minimum of 2.5 years. Thus, the anticipated completion dates below may be adjusted on the basis of actual event occurrence. ] [ Designated as safety issue: No ]
Secondary Outcome Measure ^†	To measure the effect of treatment with ezetimibe/simvastatin compared with simvastatin monotherapy on death due to any cause, non-fatal coronary events (such as heart attack), and non-fatal stroke [ Time Frame: Trial will continue until a minimum of 5,250 subjects have an primary endpoint event and each subject is followed for a minimum of 2.5 years ] [ Designated as safety issue: No ] To measure the effect of treatment with ezetimibe/simvastatin compared with simvastatin monotherapy on coronary heart disease-related death, non-fatal heart attack, and by-pass surgery [ Time Frame: Trial will continue until a minimum of 5,250 subjects have an primary endpoint event and each subject is followed for a minimum of 2.5 years ] [ Designated as safety issue: No ] To measure the effect of treatment with ezetimibe/simvastatin compared with simvastatin monotherapy on death due to any cardiovascular events, non-fatal heart attack, angina leading to hospitalization, by-pass surgery, and non-fatal stroke [ Time Frame: Trial will continue until a minimum of 5,250 subjects have an primary endpoint event and each subject is followed for a minimum of 2.5 years ] [ Designated as safety issue: No ]
Condition ^†	Hypercholesterolemia Myocardial Infarction
Intervention ^†	Drug: ezetimibe/simvastatin Drug: simvastatin
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Recruiting
Enrollment ^†	18000
Start Date ^†	October 2005
Completion Date	June 2012
Eligibility Criteria ^†	Inclusion Criteria: Clinically stable subjects may be eligible to enroll within 10 days following hospital admission with high-risk acute coronary syndrome (either STEMI or Non-STEMI or unstable angina) . Subjects not taking a statin must have an LDL-C of 125 mg/dl or less. Subjects taking s statin must have an LDL-C of 100 mg/dl or less. Exclusion Criteria: Pregnant or lactating woman, or intending to become pregnant Subject with active liver disease or persistent unexplained serum transaminase elevation Subject with a history of alcohol or drug abuse, Subject with a history of sensitivity to statin or ezetimibe A subject for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00202878
Organization ID	P04103
Secondary IDs ^††
Study Sponsor ^†	Schering-Plough
Collaborators ^††	Merck
Investigators ^†
Information Provided By	Schering-Plough
Verification Date	June 2008
First Received Date ^†	September 13, 2005
Last Updated Date	June 16, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.