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.
Information source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Diseases; Hyperlipidemia
Intervention: Placebo (unspecified) (Drug); ezetimibe (+) simvastatin (Vytorin) (Drug); niacin (+) laropiprant (MK0524A) (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
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).
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Lipid parameters efficacy comparing ezetimibe/simvastatin alone vs. ezetimibe/simvastatin plus MK0524A (CORDAPTIVE)
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: September 2008
Last updated: September 23, 2008
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