Conditions: Hypercholesterolemia
Keywords: Cholesterol High Cholesterol Elevated Cholesterol Raised Cholesterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 905
Healthy volunteers: no

Brief summary:
To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

Detailed description:
Eligible participants with screening central laboratory low-density lipoprotein cholesterol (LDL-C) values ≥ 75 mg/dL (1.9 mmol/L) were instructed to follow National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP) Therapeutic Lifestyle Changes (TLC) diet and were assigned to 1 of the following 4 background lipid-lowering therapies for a 4-week stabilization period based upon their screening LDL-C and its distance from the individual's required goal as stipulated by their NCEP ATP III risk category:

1. no drug therapy required - diet alone
2. low dose drug therapy required - diet plus atorvastatin 10 mg orally (PO) once daily (QD)
3. high dose drug therapy required - diet plus atorvastatin 80 mg PO QD
4. maximal drug therapy required - diet plus atorvastatin 80 mg PO QD plus ezetimibe 10 mg PO QD.

If the participant met entry criteria at the end of the lipid stabilization period they were randomized 2:1 to receive evolocumab 420 mg or placebo subcutaneously once a month for 52 weeks in addition to their background therapy.

Arms:
arm 1: Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy. arm 2: Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Interventions: intervention 1: Evolocumab intervention 2: Placebo intervention 3: Atorvastatin intervention 4: Ezetimibe intervention 5: Diet Only
Intervention descriptions: intervention 1: Administered by subcutaneous injection once a month intervention 2: Administered by subcutaneous injection once a month intervention 3: Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily. intervention 4: Background lipid lowering therapy: ezetimibe 10 mg orally once a day intervention 5: Diet only, no lipid lowering background drug given

Protocol document: