Conditions: Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 803
Healthy volunteers: no

Brief summary:
To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.

Detailed description:

Arms:
arm 1: Two subcutaneous (SC) injections of placebo (for alirocumab) Q2W with or without stable statin therapy for 48 weeks. arm 2: One SC injection of each Alirocumab 75 mg and placebo Q2W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk participants) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk participants) at Week 8. arm 3: Two SC injections of Alirocumab 150 mg Q4W alternating with two SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk participants) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk participants) at Week 8.

Interventions: intervention 1: Placebo (for alirocumab) intervention 2: Alirocumab intervention 3: Statin
Intervention descriptions: intervention 1: Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector. intervention 2: Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector. intervention 3: Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy

Protocol document: