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![[-]](/archive/collapse.gif "Hide most of the text in this chunk of XML") ![[+]](/archive/expand.gif "Show the hidden text in this chunk of XML") <clinical_study>
<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>
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<clinical_study>
<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>
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Enrico Veltri, MD - Group Vice President, Global Clinical Research, Cardiovascular and Metabolic Diseases
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Head, Clinical Trials Registry & Results Disclosure Group
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</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>
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</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>
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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.
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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.
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</textblock>
</brief_summary>
<detailed_descr>
<textblock>
</textblock>
</detailed_descr>
<status_block>
<status>
Recruiting
</status>
<date>
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</textblock>
</brief_summary>
<detailed_descr>
<textblock>
</textblock>
</detailed_descr>
<status_block>
<status>
Recruiting
</status>
<date>
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2008-03
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2008-05
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</date>
</status_block>
<start_date>
<date>
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</date>
</status_block>
<start_date>
<date>
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2005-10
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2006-02
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</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>
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</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>
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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
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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.
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</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>
<arm_group_label>
ezetimibe/simvastatin
</arm_group_label>
<arm_type>
Experimental
</arm_type>
<description>
<textblock>
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</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>
<arm_group_label>
ezetimibe/simvastatin
</arm_group_label>
<arm_type>
Experimental
</arm_type>
<description>
<textblock>
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ezetimibe/simvastatin 10/40 mg per day
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</textblock>
</description>
</arm_group>
<arm_group>
<arm_group_label>
simvastatin
</arm_group_label>
<arm_type>
Active Comparator
</arm_type>
<description>
<textblock>
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</textblock>
</description>
</arm_group>
<arm_group>
<arm_group_label>
simvastatin
</arm_group_label>
<arm_type>
Active Comparator
</arm_type>
<description>
<textblock>
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simvastatin 40 mg per day
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</textblock>
</description>
</arm_group>
<intervention>
<intervent_type>
Drug
</intervent_type>
<primary_name>
ezetimibe/simvastatin
</primary_name>
<description>
<textblock>
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</textblock>
</description>
</arm_group>
<intervention>
<intervent_type>
Drug
</intervent_type>
<primary_name>
ezetimibe/simvastatin
</primary_name>
<description>
<textblock>
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ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation
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ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation (if LDL-C response is inadequate, the dose of simvastatin may be increased to 80 mg)
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</textblock>
</description>
<arm_group_label>
ezetimibe/simvastatin
</arm_group_label>
<other_name>
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</textblock>
</description>
<arm_group_label>
ezetimibe/simvastatin
</arm_group_label>
<other_name>
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Vytorin, Inegy
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Vytorin
</other_name>
<other_name>
Inegy
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</other_name>
</intervention>
<intervention>
<intervent_type>
Drug
</intervent_type>
<primary_name>
simvastatin
</primary_name>
<description>
<textblock>
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</other_name>
</intervention>
<intervention>
<intervent_type>
Drug
</intervent_type>
<primary_name>
simvastatin
</primary_name>
<description>
<textblock>
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simvastatin 40 mg per day from randomization through the end of participation
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simvastatin 40 mg per day from randomization through the end of participation (if LDL-C response is inadequate, the dose of simvastatin may be increased to 80 mg)
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</textblock>
</description>
<arm_group_label>
simvastatin
</arm_group_label>
<other_name>
Zocor
</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
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.
</textblock>
</criteria>
<healthy_volunteers>
No
</healthy_volunteers>
<gender>
Both
</gender>
<minimum_age>
18 Years
</minimum_age>
<maximum_age>
</maximum_age>
</eligibility>
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</textblock>
</description>
<arm_group_label>
simvastatin
</arm_group_label>
<other_name>
Zocor
</other_name>
</intervention>
<eligibility>
<criteria>
<textblock>
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.
</textblock>
</criteria>
<healthy_volunteers>
No
</healthy_volunteers>
<gender>
Both
</gender>
<minimum_age>
18 Years
</minimum_age>
<maximum_age>
</maximum_age>
</eligibility>
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<investigator>
<role>
Study Director
</role>
<name>
John Strony, MD
</name>
<affiliation>
<agency>
Schering-Plough Research Institute
</agency>
</affiliation>
</investigator>
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| 24 |
<location>
<facility>
<name>
TIMI Study Group
</name>
<address>
<city>
Boston
</city>
<state>
Massachusetts
</state>
<zip>
02115
</zip>
<country>
United States
</country>
</address>
</facility>
<status>
Recruiting
</status>
<contact>
<name>
Amy McCagg
</name>
<phone>
800-385-4444
</phone>
<phone_ext>
</phone_ext>
<email>
amccagg@partners.org
</email>
</contact>
</location>
<keyword>
hypercholesterolemia
</keyword>
<keyword>
myocardial infarction
</keyword>
<keyword>
cholesterol
</keyword>
<keyword>
randomized controlled trials
</keyword>
<initial_release_date>
2005-09-13
</initial_release_date>
<last_release_date>
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<location>
<facility>
<name>
TIMI Study Group
</name>
<address>
<city>
Boston
</city>
<state>
Massachusetts
</state>
<zip>
02115
</zip>
<country>
United States
</country>
</address>
</facility>
<status>
Recruiting
</status>
<contact>
<name>
Amy McCagg
</name>
<phone>
800-385-4444
</phone>
<phone_ext>
</phone_ext>
<email>
amccagg@partners.org
</email>
</contact>
</location>
<keyword>
hypercholesterolemia
</keyword>
<keyword>
myocardial infarction
</keyword>
<keyword>
cholesterol
</keyword>
<keyword>
randomized controlled trials
</keyword>
<initial_release_date>
2005-09-13
</initial_release_date>
<last_release_date>
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2008-04-03
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2008-05-01
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</last_release_date>
</clinical_study>
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</last_release_date>
</clinical_study>
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