Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: April 1, 2008
Last updated: December 5, 2014
Last verified: December 2014

Collecting local data, safety and experience trial.

Condition Intervention Phase
Cardiovascular Disorder
Drug: Ezetimibe
Drug: simvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • LDL levels [ Time Frame: 42 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety measures [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Total cholesterol levels. [ Time Frame: 42 Days ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: February 2005
Study Completion Date: August 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients; Post Acute Coronary Syndrome

Exclusion Criteria:


  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00652717

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00652717     History of Changes
Other Study ID Numbers: 0653A-150, 2008_009
Study First Received: April 1, 2008
Last Updated: December 5, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 26, 2015