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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This study has been withdrawn prior to enrollment.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:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT00738985
First received: August 19, 2008
Last updated: March 23, 2015
Last verified: March 2015
August 19, 2008
March 23, 2015
November 2009
September 2010   (Final data collection date for primary outcome measure)
Lipid parameters efficacy comparing ezetimibe/simvastatin alone vs. ezetimibe/simvastatin plus MK0524A (CORDAPTIVE) [ Time Frame: 18 Week(s) ]
Same as current
Complete list of historical versions of study NCT00738985 on ClinicalTrials.gov Archive Site
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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
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.
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).
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Cardiovascular Diseases
  • Hyperlipidemia
  • 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
  • Drug: ezetimibe/simvastatin 10/20 mg + MK0524A
    ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets
    Other Names:
    • Vytorin
    • MK0653A
  • 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
    Intervention: Drug: ezetimibe/simvastatin 10/20 mg + placebo
  • 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.
    Intervention: Drug: ezetimibe/simvastatin 10/20 mg + MK0524A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Mexico
 
NCT00738985
2008_019
No
Not Provided
Not Provided
Carlos A Aguilar Salinas, Instituto Nacional de Ciencias Medicas y Nutricion
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP