<study_id>
<org_name>
SPRI
</org_name>
<org_full_name>
Schering-Plough
</org_full_name>
<org_study_id>
P04103
</org_study_id>
<secondary_id>
</secondary_id>
<nct_id>
NCT00202878
</nct_id>
</study_id>
<is_fda_regulated>
Yes
</is_fda_regulated>
<is_section_801>
Yes
</is_section_801>
<delayed_posting>
No
</delayed_posting>
<brief_title>
<textblock>
IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome:Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (Study P04103)
</textblock>
</brief_title>
<official_title>
<textblock>
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)
</textblock>
</official_title>
<study_sponsor>
<lead_sponsor>
<agency>
Schering-Plough
</agency>
</lead_sponsor>
<sponsor>
<agency>
Merck
</agency>
</sponsor>
</study_sponsor>
<resp_party>
<name_title>
Enrico Veltri, MD - Group Vice President, Global Clinical Research, Cardiovascular and Metabolic Diseases
</name_title>
<organization>
Schering-Plough
</organization>
</resp_party>
<oversight_info>
<regulatory_authority>
United States: Food and Drug Administration
</regulatory_authority>
<has_dmc>
Yes
</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
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. 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.
</textblock>
</brief_summary>
<detailed_descr>
<textblock>
</textblock>
</detailed_descr>
<status_block>
<status>
Recruiting
</status>
<date>
2008-03
</date>
</status_block>
<start_date>
<date>
2005-10
</date>
</start_date>
<end_date>
<date>
</date>
</end_date>
<last_follow_up_date
type="Anticipated"
>
<date>
2012-06
</date>
</last_follow_up_date>
<primary_compl_date
type="Anticipated"
>
<date>
2012-06
</date>
</primary_compl_date>
<phase_block>
<phase>
Phase 3
</phase>
</phase_block>
<study_type>
Interventional
</study_type>
<design>
Treatment
</design>
<design>
Randomized
</design>
<design>
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
</design>
<design>
Active Control
</design>
<design>
Parallel Assignment
</design>
<design>
Safety/Efficacy Study
</design>
<number_of_arms>
2
</number_of_arms>
<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
</measure>
<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
</time_frame>
<safety_issue>
No
</safety_issue>
</primary_outcome>
<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
</measure>
<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
</time_frame>
<safety_issue>
No
</safety_issue>
</secondary_outcome>
<secondary_outcome>
<measure>
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
</measure>
<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
</time_frame>
<safety_issue>
No
</safety_issue>
</secondary_outcome>
<secondary_outcome>
<measure>
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
</measure>
<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
</time_frame>
<safety_issue>
No
</safety_issue>
</secondary_outcome>
<enrollment
type="Anticipated"
>
18000
</enrollment>
<condition>
Hypercholesterolemia
</condition>
<condition>
Myocardial Infarction
</condition>
<arm_group>
