INdians Followed for INtensive Lipid Lowering Treatment and Its safetY (INFINITY)
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|ClinicalTrials.gov Identifier: NCT00664469|
Recruitment Status : Terminated (Poor enrollment)
First Posted : April 23, 2008
Last Update Posted : July 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Drug: ezetimibe Drug: Comparator: Simvastatin 20, 40 and 80 mg Drug: Comparator: Atorvastatin Drug: Comparator: Rosuvastatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||November 2010|
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.
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.
- The primary measure of efficacy will be the percentage of patients in each treatment arm achieving a target LDL-C > 2.0 mmol/L at week 6 assessment. This will be calculated as the percentage of patients achieving this end point at 6 weeks of treatment us [ Time Frame: 6 weeks of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664469
|Merck Frosst Canada Ltd.|
|Kirkland, Quebec, Canada, H9H 3L1|
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|