Side-by-side differences

	Before (Updated 2006_10_02)	After (Updated 2006_10_30)
1	<clinical_study> <study_id> <org_name> SPRI </org_name> <org_full_name> Schering-Plough </org_full_name> <org_study_id> P04103 </org_study_id> <nct_id> NCT00202878 </nct_id> </study_id> <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> Study to Establish the Clinical Benefit/Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin in Subjects 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> <oversight_info> <regulatory_authority> United States: Food and Drug Administration </regulatory_authority> </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>	<clinical_study> <study_id> <org_name> SPRI </org_name> <org_full_name> Schering-Plough </org_full_name> <org_study_id> P04103 </org_study_id> <nct_id> NCT00202878 </nct_id> </study_id> <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> Study to Establish the Clinical Benefit/Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin in Subjects 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> <oversight_info> <regulatory_authority> United States: Food and Drug Administration </regulatory_authority> </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>
2	2006-09	2006-10
3	</date> </status_block> <start_date> <date>	</date> </status_block> <start_date> <date>
4		2006-02
5	</date> </start_date> <end_date> <date> </date> </end_date> <last_follow_up_date> <date> </date> </last_follow_up_date> <last_data_entry_date> <date> </date> </last_data_entry_date> <phase_block> <phase> Phase 3 </phase> </phase_block> <study_type> Interventional </study_type> <design> Treatment </design> <design> Randomized </design> <design> Double Blind </design> <design> Active Control </design> <design> Parallel Assignment </design> <design> Safety/Efficacy Study </design> <condition> Hypercholesterolemia </condition> <condition> Myocardial Infarction </condition> <intervention> <intervent_type> Drug </intervent_type> <primary_name> ezetimibe/simvastatin combination 10 mg/40 mg (VYTORIN) </primary_name> </intervention> <intervention> <intervent_type> Drug </intervent_type> <primary_name> simvastatin 40 mg (ZOCOR) </primary_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> <patients> </patients> <expected_enrollment> </expected_enrollment> <gender> Both </gender> <minimum_age> 18 Years </minimum_age> <maximum_age>	</date> </start_date> <end_date> <date> </date> </end_date> <last_follow_up_date> <date> </date> </last_follow_up_date> <last_data_entry_date> <date> </date> </last_data_entry_date> <phase_block> <phase> Phase 3 </phase> </phase_block> <study_type> Interventional </study_type> <design> Treatment </design> <design> Randomized </design> <design> Double Blind </design> <design> Active Control </design> <design> Parallel Assignment </design> <design> Safety/Efficacy Study </design> <condition> Hypercholesterolemia </condition> <condition> Myocardial Infarction </condition> <intervention> <intervent_type> Drug </intervent_type> <primary_name> ezetimibe/simvastatin combination 10 mg/40 mg (VYTORIN) </primary_name> </intervention> <intervention> <intervent_type> Drug </intervent_type> <primary_name> simvastatin 40 mg (ZOCOR) </primary_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> <patients> </patients> <expected_enrollment> </expected_enrollment> <gender> Both </gender> <minimum_age> 18 Years </minimum_age> <maximum_age>
6	N/A
7	</maximum_age> </eligibility> <location> <facility> <name> The 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> Public Contact </name> <phone> 800-385-4444 </phone> <phone_ext> </phone_ext> <email> </email> </contact> <contact> <name> Public Contact </name> <phone> 617-278-0145 </phone> <phone_ext> </phone_ext> <email> </email> </contact> </location> <location> <facility> <name> Duke Clinical Research Institute </name> <address> <city> Durham </city> <state> North Carolina </state> <zip> 27705 </zip> <country> United States </country> </address> </facility> <status> Recruiting </status> <contact> <name> Public Contact </name> <phone> 919-668-8700 </phone> <phone_ext> </phone_ext> <email> </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>	</maximum_age> </eligibility> <location> <facility> <name> The 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> Public Contact </name> <phone> 800-385-4444 </phone> <phone_ext> </phone_ext> <email> </email> </contact> <contact> <name> Public Contact </name> <phone> 617-278-0145 </phone> <phone_ext> </phone_ext> <email> </email> </contact> </location> <location> <facility> <name> Duke Clinical Research Institute </name> <address> <city> Durham </city> <state> North Carolina </state> <zip> 27705 </zip> <country> United States </country> </address> </facility> <status> Recruiting </status> <contact> <name> Public Contact </name> <phone> 919-668-8700 </phone> <phone_ext> </phone_ext> <email> </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>
8	2006-09-29	2006-10-27
9	</last_release_date> </clinical_study>	</last_release_date> </clinical_study>

1

<clinical_study>

<study_id>

<org_name>

SPRI

</org_name>

<org_full_name>

Schering-Plough

</org_full_name>

<org_study_id>

P04103

</org_study_id>

<nct_id>

NCT00202878

</nct_id>

</study_id>

<brief_title>

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

</textblock>

</brief_title>

<official_title>

Study to Establish the Clinical Benefit/Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin in Subjects With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial – IMPROVE IT)

</textblock>

</official_title>

<study_sponsor>

<lead_sponsor>

Schering-Plough

</agency>

</lead_sponsor>

Merck

</agency>

</sponsor>

</study_sponsor>

<oversight_info>

<regulatory_authority>

United States: Food and Drug Administration

</regulatory_authority>

</oversight_info>

<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. 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>

</detailed_descr>

<status_block>

Recruiting

</status>

<date>

<clinical_study>

<study_id>

<org_name>

SPRI

</org_name>

<org_full_name>

Schering-Plough

</org_full_name>

<org_study_id>

P04103

</org_study_id>

<nct_id>

NCT00202878

</nct_id>

</study_id>

<brief_title>

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

</textblock>

</brief_title>

<official_title>

Study to Establish the Clinical Benefit/Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin in Subjects With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial – IMPROVE IT)

</textblock>

</official_title>

<study_sponsor>

<lead_sponsor>

Schering-Plough

</agency>

</lead_sponsor>

Merck

</agency>

</sponsor>

</study_sponsor>

<oversight_info>

<regulatory_authority>

United States: Food and Drug Administration

</regulatory_authority>

</oversight_info>

<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. 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>

</detailed_descr>

<status_block>

Recruiting

</status>

<date>

3

</date>

</status_block>

<start_date>

<date>

</date>

</status_block>

<start_date>

<date>

5

</date>

</start_date>

<end_date>

<date>

</date>

</end_date>

<last_follow_up_date>

<date>

</date>

</last_follow_up_date>

<last_data_entry_date>

<date>

</date>

</last_data_entry_date>

<phase_block>

<phase>

Phase 3

</phase>

</phase_block>

<study_type>

Interventional

</study_type>

Treatment

</design>

Randomized

</design>

Double Blind

</design>

Active Control

</design>

Parallel Assignment

</design>

Safety/Efficacy Study

</design>

Hypercholesterolemia

</condition>

Myocardial Infarction

</condition>

<intervent_type>

Drug

</intervent_type>

<primary_name>

ezetimibe/simvastatin combination 10 mg/40 mg (VYTORIN)

</primary_name>

</intervention>

<intervent_type>

Drug

</intervent_type>

<primary_name>

simvastatin 40 mg (ZOCOR)

</primary_name>

</intervention>

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>

</patients>

<expected_enrollment>

</expected_enrollment>

Both

</gender>

<minimum_age>

18 Years

</minimum_age>

<maximum_age>

</date>

</start_date>

<end_date>

<date>

</date>

</end_date>

<last_follow_up_date>

<date>

</date>

</last_follow_up_date>

<last_data_entry_date>

<date>

</date>

</last_data_entry_date>

<phase_block>

<phase>

Phase 3

</phase>

</phase_block>

<study_type>

Interventional

</study_type>

Treatment

</design>

Randomized

</design>

Double Blind

</design>

Active Control

</design>

Parallel Assignment

</design>

Safety/Efficacy Study

</design>

Hypercholesterolemia

</condition>

Myocardial Infarction

</condition>

<intervent_type>

Drug

</intervent_type>

<primary_name>

ezetimibe/simvastatin combination 10 mg/40 mg (VYTORIN)

</primary_name>

</intervention>

<intervent_type>

Drug

</intervent_type>

<primary_name>

simvastatin 40 mg (ZOCOR)

</primary_name>

</intervention>

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>

</patients>

<expected_enrollment>

</expected_enrollment>

Both

</gender>

<minimum_age>

18 Years

</minimum_age>

<maximum_age>

7

</maximum_age>

</eligibility>

<name>

The TIMI Study Group

</name>

<city>

Boston

</city>

<state>

Massachusetts

</state>

<zip>

02115

</zip>

United States

</country>

</address>

</facility>

Recruiting

</status>

<name>

Public Contact

</name>

<phone>

800-385-4444

</phone>

<phone_ext>

</phone_ext>

<email>

</email>

</contact>

<name>

Public Contact

</name>

<phone>

617-278-0145

</phone>

<phone_ext>

</phone_ext>

<email>

</email>

</contact>

</location>

<name>

Duke Clinical Research Institute

</name>

<city>

Durham

</city>

<state>

North Carolina

</state>

<zip>

27705

</zip>

United States

</country>

</address>

</facility>

Recruiting

</status>

<name>

Public Contact

</name>

<phone>

919-668-8700

</phone>

<phone_ext>

</phone_ext>

<email>

</email>

</contact>

</location>

hypercholesterolemia

</keyword>

myocardial infarction

</keyword>

cholesterol

</keyword>

randomized controlled trials

</keyword>

<initial_release_date>

2005-09-13

</initial_release_date>

<last_release_date>

</maximum_age>

</eligibility>

<name>

The TIMI Study Group

</name>

<city>

Boston

</city>

<state>

Massachusetts

</state>

<zip>

02115

</zip>

United States

</country>

</address>

</facility>

Recruiting

</status>

<name>

Public Contact

</name>

<phone>

800-385-4444

</phone>

<phone_ext>

</phone_ext>

<email>

</email>

</contact>

<name>

Public Contact

</name>

<phone>

617-278-0145

</phone>

<phone_ext>

</phone_ext>

<email>

</email>

</contact>

</location>

<name>

Duke Clinical Research Institute

</name>

<city>

Durham

</city>

<state>

North Carolina

</state>

<zip>

27705

</zip>

United States

</country>

</address>

</facility>

Recruiting

</status>

<name>

Public Contact

</name>

<phone>

919-668-8700

</phone>

<phone_ext>

</phone_ext>

<email>

</email>

</contact>

</location>

hypercholesterolemia

</keyword>

myocardial infarction

</keyword>

cholesterol

</keyword>

randomized controlled trials

</keyword>

<initial_release_date>

2005-09-13

</initial_release_date>

<last_release_date>

9

</last_release_date>

</clinical_study>

</last_release_date>

</clinical_study>

Changes to NCT00202878 on 2006_10_30

Key

Before

(Updated 2006_10_02)

After

(Updated 2006_10_30)

Before

(Updated 2006_10_02)

After

(Updated 2006_10_30)