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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00652717

Purpose

Collecting local data, safety and experience trial.

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

MedlinePlus related topics: Cholesterol Heart Attack Statins

Drug Information available for: Simvastatin Ezetimibe Cholest-5-en-3-ol (3beta)-

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

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
1: Experimental 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. Drug: simvastatin simvastatin (prescribed clinically suitable dose by the physician), for mean follow up of 42 days.
2: Active Comparator 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.

Eligibility

Criteria

Inclusion Criteria:

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

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

Study placed in the following topic categories:

Heart Diseases
Simvastatin
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases

Ezetimibe
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009