Conditions: Hyperlipidemia
Keywords: High cholesterol Proprotein convertase subtilisin/kexin type 9 (PCSK9) Treatment for high cholesterol Lowering cholesterol Lowering high cholesterol Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 411
Healthy volunteers: no

Brief summary:
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.

Detailed description:

Arms:
arm 1: Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. arm 2: Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks. arm 3: Participants received 10 mg ezetimibe orally once a day for 12 weeks. arm 4: Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. arm 5: Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. arm 6: Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. arm 7: Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. arm 8: Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. arm 9: Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Interventions: intervention 1: Evolocumab intervention 2: Ezetimibe intervention 3: Placebo to Evolocumab
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered orally once a day intervention 3: Administered by subcutaneous injection

Protocol document: