Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 (MENDEL-2)

The primary hypothesis is that dosing regimens of monotherapy Evolocumab(AMG 145) will be well tolerated and will result in greater reduction of Low Density Lipoprotein -Cholesterol, than placebo and ezetimibe in subjects with a 10-year Framingham risk score of 10% or less.

Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With Evolocumab(AMG 145) in Subjects With a 10-Year Framingham Risk Score of 10% or Less
Enrollment: 614
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Arm 1 (Dose 1 of subcutaneous Evolocumab (AMG 145) every 2 weeks and placebo orally/daily)
- Experimental: Arm 2 (Dose 2 of subcutaneous Evolocumab (AMG 145) monthly and placebo orally/daily)
- Active Comparator: Arm 3 (Dose 3 of subcutaneous placebo every 2 weeks and Ezetimibe orally/daily)
- Active Comparator: Arm 4 (Dose 4 of subcutaneous placebo monthly and Ezetimibe orally/daily)
- Placebo Comparator: Arm 5 (Dose 5 of subcutaneous placebo every 2 weeks and placebo orally/daily)
- Placebo Comparator: Arm 6 (Dose 6 of subcutaneous placebo monthly and placebo orally/daily)