A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00132717

Purpose

The purpose of this study is to investigate the effect of an investigational cholesterol-lowering drug in patients who are currently taking an approved medication for hypercholesterolemia (high cholesterol levels) and have been hospitalized for a heart problem.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: MK0653A (ezetimibe [+] simvastatin) Drug: Comparator: atorvastatin Drug: Comparator: fluvastatin Drug: Comparator: lovastatin Drug: Comparator: pravastatin Drug: Comparator: rosuvastatin Drug: Comparator: simvastatin	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Pravastatin Pravastatin sodium Atorvastatin Atorvastatin calcium Rosuvastatin Rosuvastatin calcium Simvastatin Ezetimibe Lovastatin Fluvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination Tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary Event

Further study details as provided by Merck:

Primary Outcome Measures:

Evaluate the effectiveness of MK0653A compared to doubling the statin dose as shown by the low-density lipoprotein cholesterol (LDL-C) values achieved after 12 weeks of treatment [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the effect of MK0653A compared to doubling the statin dose on total cholesterol (TC) after 12 weeks [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	450
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients greater than 18 years old, who were admitted to a hospital for an investigation of a heart problem and are currently receiving an approved medication to lower cholesterol

Exclusion Criteria:

Patients who have congestive heart failure (CHF), uncontrolled high blood pressure, poorly controlled blood sugar, impaired kidney function, or HIV.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132717

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Reckless JP, Henry P, Pomykaj T, Lim ST, Massaad R, Vandormael K, Johnson-Levonas AO, Lis K, Brudi P, Allen C. Lipid-altering efficacy of ezetimibe/simvastatin 10/40 mg compared with doubling the statin dose in patients admitted to the hospital for a recent coronary event: the INFORCE study. Int J Clin Pract. 2008 Apr;62(4):539-54. Epub 2008 Feb 11.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_046, MK0653A-808
Study First Received:	August 2, 2005
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00132717
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Hyperlipidemias
Metabolic Diseases
Simvastatin
Ezetimibe
Fluvastatin
Pravastatin
Rosuvastatin

Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lovastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009