Conditions: Hyperlipidemia
Keywords: Proprotein convertase subtilisin/kexin type 9 (PCSK9) Cholesterol High Cholesterol Raised Cholesterol Elevated Cholesterol Statin intolerant Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 160
Healthy volunteers: no

Brief summary:
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Detailed description:

Arms:
arm 1: Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. arm 2: Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. arm 3: Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. arm 4: Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. arm 5: 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: