Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Patients With Mixed Hyperlipidemia and Two or More Risk Factors to Cardiovascular Disease. - Full Text View

Purpose

To measure the percentage of patients who achieve all the treatment lipid goals being treated with ezetimibe/simvastatin 10/20 with or without MK0524A (1-2 g/day).

Condition	Intervention	Phase
Cardiovascular Diseases Hyperlipidemia	Drug: Placebo (unspecified) Drug: ezetimibe (+) simvastatin (Vytorin) Drug: niacin (+) laropiprant (MK0524A)	Phase IV

Genetics Home Reference related topics:

cholesteryl ester storage disease Farber lipogranulomatosis long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

ChemIDplus related topics:

Laropiprant Simvastatin Ezetimibe Niacin Niacin hydrochloride Vytorin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Patients With Mixed Hyperlipidemia and Two or More Risk Factors to Cardiovascular Disease.

Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:

Lipid parameters efficacy comparing ezetimibe/simvastatin alone vs. ezetimibe/simvastatin plus MK0524A (CORDAPTIVE) [ Time Frame: 18 Week(s) ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ezetimibe (+) simvastatin 10/20 mg + placebo for 6-12 weeks	Drug: Placebo (unspecified) Patients will receive placebo for up to 22 weeks. Tablets Drug: ezetimibe (+) simvastatin (Vytorin) ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets
2: Experimental ezetimibe (+) simvastatin 10/20 mg + MK0524A 1 gr for 6 weeks, if efficacy achieved will continue with ezetimibe (+) simvastatin 10/20 mg + MK0524A 1 gr + placebo; if not achieved, will receive ezetimibe (+) simvastatin 10/20 mg + MK0524A 2 gr for 6 weeks.	Drug: Placebo (unspecified) Patients will receive placebo for up to 22 weeks. Tablets Drug: ezetimibe (+) simvastatin (Vytorin) ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets Drug: niacin (+) laropiprant (MK0524A) niacin (+) laropiprant 1 gr or 2 gr for 6-12 weeks . Tablets

Detailed Description:

Patients will receive placebo for 4 weeks, then Vytorin 10/20 mg for 6 weeks, if efficacy of treatment is achieved, they will continue with Vytorin 10/20 mg + placebo for 12 more weeks, if not achieved, will receive Vytorin 10/20 mg + MK0524A 1 gr for 6 weeks, if efficacy achieved will continue with Vytorin 10/20 mg + MK0524A 1 gr + placebo; if not achieved, will receive Vytorin 10/20 mg + MK0524A 2 gr for 6 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient Without Ischemic Cardiovascular Disease Who During The Treatment With Statin Have LDL-C <130 Mg/Dl at Visit 1 Or Within The 6 Month Period Before Visit 1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738985

Sponsors and Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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_019, MK0653A-165
First Received:	August 19, 2008
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00738985
Health Authority:	Mexico: Ministry of Health

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors

Hyperlipidemias

Metabolic Diseases

Simvastatin

Ezetimibe

Combined hyperlipidemia, familial

Metabolism, Inborn Errors

Nicotinic Acids

Genetic Diseases, Inborn

Hyperlipidemia, Familial Combined

Metabolic disorder

Niacin

Dyslipidemias

Lipid Metabolism Disorders

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 October 15, 2008

Sponsors and Collaborators:	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Merck
Information provided by:	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:	NCT00738985