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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00652717
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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
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:

U.S. FDA Resources

Further study details as provided by Merck:

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
Primary Completion Date: December 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

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

Inclusion Criteria:

  • Patients; Post Acute Coronary Syndrome

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652717

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00652717     History of Changes
Other Study ID Numbers: 2008_009
Study First Received: April 1, 2008
Last Updated: April 1, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Anticholesteremic Agents
 Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013