Hypercholesterolemia Clinical Trial
Official title:
Long-Term, Open-Label, Safety and Tolerability Study of Ezetimibe (SCH 58235) in Addition to Atorvastatin in Subjects With Coronary Heart Disease or Multiple Risk Factors and With Primary Hypercholesterolemia Not Controlled by a Starting Dose (10 mg) of Atorvastatin
The purpose of this study was to evaluate the long-term safety and tolerability of ezetimibe 10 mg once daily co-administered with atorvastatin 10 to 80 mg daily for up to 12 consecutive months in participants with heterozygous familial hypercholesterolemia (HeFH) or in participants with coronary heart disease (CHD) or multiple cardiovascular risk factors and primary hypercholesterolemia not controlled by a starting dose (10 mg daily) of atorvastatin.
Adult participants with a diagnosis of HeFH or CHD or multiple risk factors (≥2) and with primary hypercholesterolemia who had successfully completed the 14-week, double-blind efficacy and safety study of ezetimibe co-administered with atorvastatin (Protocol No. P00693/MK-0653-030; NCT03867318) were eligible for enrollment in this long-term extension study. ;
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