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

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: ezetimibe/simvastatin 10/20 mg + placebo Drug: ezetimibe/simvastatin 10/20 mg + MK0524A	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Drug Information available for: Simvastatin Ezetimibe Vytorin Laropiprant

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:	November 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: ezetimibe/simvastatin 10/20 mg + placebo The intervention consisted of an isocaloric diet, an exercise program (30 min/day of aerobic activity) and ezetimibe (+) simvastatin 10/20 mg + placebo for 12 weeks. Safety and efficacy parameters are measured at baseline and 12 weeks later	Drug: ezetimibe/simvastatin 10/20 mg + placebo Patients will receive placebo (sugar tablets) for up to 22 weeks. Other Name: No other drug is used per protocol in this study arm
Active Comparator: ezetimibe/simvastatin 10/20 mg + MK0524A The intervention consisted of an isocaloric diet, an exercise program (30 min/day of aerobic activity) and 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: ezetimibe/simvastatin 10/20 mg + MK0524A ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets Other Names: Vytorin MK0653A

Arms

Assigned Interventions

Placebo Comparator: ezetimibe/simvastatin 10/20 mg + placebo

The intervention consisted of an isocaloric diet, an exercise program (30 min/day of aerobic activity) and ezetimibe (+) simvastatin 10/20 mg + placebo for 12 weeks. Safety and efficacy parameters are measured at baseline and 12 weeks later

Drug: ezetimibe/simvastatin 10/20 mg + placebo

Patients will receive placebo (sugar tablets) for up to 22 weeks.

Other Name: No other drug is used per protocol in this study arm

Active Comparator: ezetimibe/simvastatin 10/20 mg + MK0524A

The intervention consisted of an isocaloric diet, an exercise program (30 min/day of aerobic activity) and 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: ezetimibe/simvastatin 10/20 mg + MK0524A

ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets

Other Names:

Vytorin
MK0653A

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

Exclusion criteria:

The use of any other lipid lowering agent
Life expectancy lower than a year.
Any condition that may interfere with the adherence to the study protocol

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:	Carlos A Aguilar Salinas, Instituto Nacional de Ciencias Medicas y Nutricion
ClinicalTrials.gov Identifier:	NCT00738985 History of Changes
Other Study ID Numbers:	2008_019
Study First Received:	August 19, 2008
Last Updated:	October 21, 2011
Health Authority:	Mexico: Ministry of Health

Additional relevant MeSH terms:

Cardiovascular Diseases
Hyperlipidemias
Hyperlipidemia, Familial Combined
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Simvastatin

Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012