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

This study has been withdrawn prior to enrollment.
(The study was cancelled due to budget limitations)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738985
First Posted: August 21, 2008
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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) ]

Enrollment: 0
Study Start Date: November 2009
Study Completion Date: September 2010
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

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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738985


Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

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
First Submitted: August 19, 2008
First Posted: August 21, 2008
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipidemias
Hyperlipoproteinemias
Hyperlipidemia, Familial Combined
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Simvastatin
Ezetimibe
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors