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This study has been withdrawn prior to enrollment.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: October 21, 2011
Last verified: September 2010

August 19, 2008
October 21, 2011
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) ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
100
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00738985
2008_019
No
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
September 2010

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