Study To Assess The Efficacy Of A Cholesterol Lowering Drug On Top Of Statins In Patients After Myocardial Infarction (MI)(0653A-150)

Phase 4

Completed

• Conditions: Cardiovascular Disorder
• Interventions: Drug: Ezetimibe; Drug: simvastatin

• Registration Number: NCT00652717
• Lead Sponsor: Organon and Co

Brief Summary

Collecting local data, safety and experience trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-01
• Primary Completion: 2005-02-15
• Study Completion: 2005-08-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-04
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Patients; Post Acute Coronary Syndrome

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ezetimibe	arm 1 - Ezetimibe 10 mg daily that was added on Statin Therapy (prescribed clinically suitable dose by the physician).
1	simvastatin	arm 1 - Ezetimibe 10 mg daily that was added on Statin Therapy (prescribed clinically suitable dose by the physician).
2	simvastatin	arm 2- simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.

Primary Outcome Measures

Name	Time	Method
LDL levels	42 Days

Secondary Outcome Measures

Name	Time	Method
Total cholesterol levels.	42 Days
Safety measures	42 days