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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00664469 |
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 |
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Hypercholesterolemia |
Drug: ezetimibe Drug: Simvastatin 20, 40 and 80 mg Drug: Comparator: Atorvastatin Drug: Comparator: Rosuvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 300 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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group 1: Experimental
group 1: 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.
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Drug: ezetimibe
ezetimibe 10 mg/day over a 6-week course of treatment.
Drug: 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.
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Group 2: Active Comparator
Group 2: 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.
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Drug: 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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_006, MK0653-153 |
Study First Received: | April 1, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00664469 |
Health Authority: | Canada: Canadian Institutes of Health Research |
Rosuvastatin Metabolic Diseases Hyperlipidemias Simvastatin Ezetimibe |
Metabolic disorder Hypercholesterolemia Atorvastatin Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |