Conditions: Primary Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 125
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Detailed description:

Arms:
arm 1: Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg arm 2: Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg arm 3: Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg

Interventions: intervention 1: Ezetimibe intervention 2: Atorvastatin intervention 3: Atorvastatin intervention 4: Rosuvastatin
Intervention descriptions: intervention 1: 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16) intervention 2: 1 tablet of 10 mg daily for 12 weeks (Weeks 5-16) intervention 3: 2 tablets of 10 mg daily for 12 weeks (Weeks 5-16) intervention 4: 1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

Protocol document: