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.

This study is not yet open for participant recruitment.

Verified by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, September 2008

First Received: August 19, 2008 Last Updated: September 23, 2008 History of Changes

Sponsor:	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborator:	Merck
Information provided by:	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:	NCT00738985

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

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.

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis primary carnitine deficiency

Drug Information available for: Niacin Simvastatin Niacinamide Ezetimibe Vytorin Laropiprant Niacin hydrochloride

U.S. FDA Resources

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

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_019, MK0653A-165
Study First Received:	August 19, 2008
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00738985 History of Changes
Health Authority:	Mexico: Ministry of Health

Additional relevant MeSH terms:

Lipid Metabolism, Inborn Errors
Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Therapeutic Uses
Cardiovascular Diseases
Hyperlipidemia, Familial Combined
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 20, 2009