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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00652717
Collaborator
(none)
280
Enrollment
2
Arms
6
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Collecting local data, safety and experience trial.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 1, 2005
Actual Primary Completion Date :
Feb 15, 2005
Actual Study Completion Date :
Aug 4, 2005

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. LDL levels [42 Days]

    Secondary Outcome Measures

    1. Safety measures [42 days]

    2. Total cholesterol levels. [42 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients; Post Acute Coronary Syndrome
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00652717
    Other Study ID Numbers:
    • 0653A-150
    • 2008_009
    First Posted:
    Apr 4, 2008
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Simvastatin
    Ezetimibe

    Study Results

    No Results Posted as of Feb 18, 2022