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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652717
First Posted: April 4, 2008
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • LDL levels [ Time Frame: 42 Days ]

Secondary Outcome Measures:
  • Safety measures [ Time Frame: 42 days ]
  • Total cholesterol levels. [ Time Frame: 42 Days ]

Enrollment: 280
Actual Study Start Date: February 1, 2005
Study Completion Date: August 4, 2005
Primary Completion Date: February 15, 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients; Post Acute Coronary Syndrome

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652717


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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00652717     History of Changes
Other Study ID Numbers: 0653A-150
2008_009
First Submitted: April 1, 2008
First Posted: April 4, 2008
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Cardiovascular Diseases
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors