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

August 12, 2024 updated by: Organon and Co

A Multicenter, Open Study To Evaluate The Efficacy Of Ezetimibe 10 Mg Added On Statin Therapy, In Reducing LDL Cholesterol To Target Levels In Patients After Acute Coronary Syndrome

Collecting local data, safety and experience trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients; Post Acute Coronary Syndrome

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
arm 1 - Ezetimibe 10 mg daily that was added on Statin Therapy (prescribed clinically suitable dose by the physician).
Drug: Ezetimibe
Ezetimibe 10 mg daily for 42 days.
Other Names:
  • Ezetrol®
  • Zetia®
  • MK0653
Drug: simvastatin
simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.
Other Names:
  • Zocor®
  • MK0733
Active Comparator: 2
arm 2- simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.
Drug: simvastatin
simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.
Other Names:
  • Zocor®
  • MK0733

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LDL levels
Time Frame: 42 Days
42 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety measures
Time Frame: 42 days
42 days
Total cholesterol levels.
Time Frame: 42 Days
42 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2005

Primary Completion (Actual)

February 15, 2005

Study Completion (Actual)

August 4, 2005

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimated)

April 4, 2008

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0653A-150
  • 2008_009

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe