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| Sponsor: | Sunnybrook Health Sciences Centre |
|---|---|
| Collaborators: |
Merck Frosst Canada Ltd. Schering-Plough |
| Information provided by: | Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT00664469 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: ezetimibe Drug: Comparator: Simvastatin 20, 40 and 80 mg Drug: Comparator: Atorvastatin Drug: Comparator: Rosuvastatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | INdians Followed for INtensive Lipid Lowering Treatment and Its safetY: 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 |
| Enrollment: | 64 |
| Study Start Date: | August 2007 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EZE+statin
ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.
|
Drug: ezetimibe
ezetimibe 10 mg/day over a 6-week course of treatment.
|
|
Active Comparator: Stat2
patients on statins has their dose doubled for 6 weeks followed by another 6 weeks in which ezetimibe is added or the statin dose is doubled again.
|
Drug: Comparator: Simvastatin 20, 40 and 80 mg
Simvastatin 20, 40 and 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.
Drug: Comparator: Atorvastatin
Atorvastatin 20, 40 & 80 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.
Drug: Comparator: Rosuvastatin
Rosuvastatin 10, 20 & 40 mg; actual statin regimen for 6 weeks followed by another 6 weeks if at goal or statin dose can be doubled.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Quebec | |
| Merck Frosst Canada Ltd. | |
| Kirkland, Quebec, Canada, H9H 3L1 | |
| Study Director: | Medical Monitor | Merck |
More Information
| Responsible Party: | Dr Mina Madan/Cardiologist, Schulich Heart Centre, Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT00664469 History of Changes |
| Other Study ID Numbers: | 2008_006, MK0653-153 |
| Study First Received: | April 1, 2008 |
| Last Updated: | July 27, 2011 |
| Health Authority: | Canada: Health Canada |
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Simvastatin Atorvastatin Rosuvastatin Ezetimibe |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Anticholesteremic Agents Enzyme Inhibitors |