Conditions: Hyperlipidemia
Keywords: High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 615
Healthy volunteers: no

Brief summary:
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

Detailed description:

Arms:
arm 1: Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks. arm 2: Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. arm 3: Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. arm 4: Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. arm 5: Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. arm 6: Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.

Interventions: intervention 1: Evolocumab intervention 2: Ezetimibe intervention 3: Placebo to Evolocumab intervention 4: Placebo to Ezetimibe
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered orally once a day intervention 3: Administered by subcutaneous injection intervention 4: Administered orally once daily

Protocol document: