Conditions: Primary Hyperlipidemia and Mixed Dyslipidemia
Keywords: Raised cholesterol Cholesterol Elevated Cholesterol Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 89
Healthy volunteers: yes

Brief summary:
This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.

Detailed description:

Arms:
arm 1: Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks. arm 2: Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks. arm 3: Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks. arm 4: Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.

Interventions: intervention 1: Evolocumab intervention 2: Atorvastatin intervention 3: Placebo to Evolocumab intervention 4: Placebo to Atorvastatin
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by mouth intervention 3: Administered by subcutaneous injection intervention 4: Administered by mouth

Protocol document: