drugset / Trial / NCT01953328
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.
Timeline
- Start
- 2013-10
- Primary completion
- 2014-06
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evolocumab | Monoclonal antibody | 140 mg | Subcutaneous |
| Subject | Evolocumab | Monoclonal antibody | 420 mg | Subcutaneous |
| Background | Atorvastatin | Small molecule | 5 mg | Oral |
| Background | Atorvastatin | Small molecule | 20 mg | Oral |