Conditions: Hypercholesterolemia Heterozygous Familial Hypercholesterolemia
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief summary:
This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up to 20 mg. There is no formal hypothesis for the study.

Detailed description:

Arms:
arm 1: one EZ 10 mg/Atorva 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks. arm 2: one EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.

Interventions: intervention 1: EZ 10 mg/Atorva 20 mg FDC intervention 2: EZ 10 mg/Atorva 10 mg FDC
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: