Status:
COMPLETED
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular...
Detailed Description
This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases; each 6 weeks in ...
Eligibility Criteria
Inclusion
- Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
- Patient is willing to maintain a cholesterol lowering diet during the study
- Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study
Exclusion
- Patient is Asian
- Patient routinely has more than 2 alcoholic drinks per day
- Female patient is pregnant or breastfeeding
- Patient has congestive heart failure
- Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
- Patient has uncontrolled cardiac arrhythmias
- Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
- Patient has uncontrolled high blood pressure
- Patient has kidney disease
- Patient has any disease known to influence blood lipid levels
- Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
- Patient has poorly controlled or newly diagnosed diabetes
- Patient is known to be HIV positive
- Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
1547 Patients enrolled
Trial Details
Trial ID
NCT01154036
Start Date
July 1 2010
End Date
October 1 2012
Last Update
February 9 2022
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