To Assess The Safety And Effectiveness Of Ezetimibe Co-Administered With Any Statin Compared To Doubling Of Current Statin Daily Dose In South Asian Canadians
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: ezetimibe (Drug); Simvastatin 20, 40 and 80 mg (Drug); Comparator: Atorvastatin (Drug); Comparator: Rosuvastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
In South Asian Canadians with documented coronary artery disease or diabetes and
hypercholesterolemia with LDL-C levels > 2. 0 mmol/L after 4 weeks of monotherapy with any
statin: To compare the percent (%) of patients who achieve an LDL-C concentration of >/=
2. 0mmol/L after a 6-week course of treatment with ezetimibe 10 mg/day co-administered with
any statin at any dose versus doubling of the current statin dose.
Clinical Details
Official title: To Assess The Safety And Effectiveness Of Ezetimibe Co-Administered With Any Statin Compared To Doubling Of Current Statin Daily Dose In South Asian Canadians
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary measure of efficacy will be the percentage of patients in each treatment arm achieving a target LDL-C of 2.0 mmol/L at week 6 assessment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient Is Of South Asian Descent, Specifically Canadian Citizens Or Landed Immigrants
With Ethnic Background From India, Pakistan, Nepal, Bangladesh Or Sri Lanka
- Patients With A Diagnosis Of Primary Hypercholesterolemia And Who Are Defined As Being
"High Risk" With A Diagnosis Of Cad Or Diabetes, Either By Past Medical History Or By
Angiographic Or Laboratory Evidence
- The Patient Has Serum Ldl-C > 2. 0 Mmol/L While On Any Statin At Below Maximum (10 Mg,
20 Mg Or 40 Mg/Day) Daily Dose For A Minimum Of Four Weeks Prior To The Baseline
Visit
Locations and Contacts
Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Michel Cimon, Phone: 514-428-2605
Additional Information
Starting date: August 2007
Last updated: January 8, 2009
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