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Clinical trial

A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment

ID
Name
0653A-809
Description
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
Trial arms
Trial start
2007-02-01
Estimated PCD
2008-03-01
Trial end
2008-03-01
Status
Completed
Phase
Early phase I
Treatment
ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.
Arms:
1
Other names:
MK0653A, Vytorin®
Comparator : rosuvastatin calcium
rosuvastatin 10mg. The treatment duration will be 6 weeks.
Arms:
2
Comparator: Placebo (unspecified)
rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.
Arms:
1
Comparator: Placebo (unspecified)
ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.
Arms:
2
Size
618
Primary endpoint
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment
Baseline and 6 weeks
Eligibility criteria
Inclusion Criteria: * Participant is currently taking a statin medication for the treatment of high cholesterol * Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl Exclusion Criteria: * Women who are pregnant or nursing, or women who intend to become pregnant * Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 618, 'type': 'ACTUAL'}}
Updated at
2024-05-16

1 organization

3 products

1 indication

Organization
Organon and Co
Product
Ezetimibe + Simvastatin
Indication
Hypercholesterolemia
Product
Rosuvastatin
Product
Comparator