Repatha™

Generic Name: evolocumab
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20080398HYPERCHOLESTEROLEMIA1b

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 145 in Subjects with Hyperlipidemia on Stable Doses of a Statin

20090158HYPERCHOLESTEROLEMIA2

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Effect of AMG 145 on LDL-C in Subjects With Heterozygous Familial Hypercholesterolemia.

20090159HYPERCHOLESTEROLEMIA2

A Phase 2, Randomized, Active-Control, Dose-Ranging Study to Evaluate the LDL-C Lowering Properties of AMG 145, Compared to Ezetimibe, When Used Alone or With Low-Dose Statin, in Statin-Intolerant Subjects with Dyslipidemia.

20101154HYPERCHOLESTEROLEMIA2

A Randomized, Multicenter, Blinded, Study to Evaluate the Safety and Efficacy of Subcutaneous AMG 145 compared with Ezetimibe and Placebo in Low Cardiovascular Risk Subjects with Dyslipidemia

20101155HYPERCHOLESTEROLEMIA2

A Phase 2, Randomized, Double-Blind, Placebo and Active Controlled, Dose-Ranging, Multiple-Dose, Parallel-Group Study to Evaluate The LDL-C Lowering Properties of AMG 145, Compared to Placebo and Ezetimibe When Used as Add-on Therapy in Dyslipidemic

20110109HYPERCHOLESTEROLEMIA3

A Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 on LDL-C in Hypercholesterolemic Subjects

20110114HYPERCHOLESTEROLEMIA3

A Double-blind, Randomized, Placebo and Ezetimibe controlled, Multicenter Study to Evaluate Safety and Efficacy of AMG 145 in Subjects With a 10 Year Framingham Risk Score of 10% or Less and Currently Not Receiving Prescription Lipid-lowering Therapy

20110115HYPERCHOLESTEROLEMIA3

A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

20110116HYPERCHOLESTEROLEMIA3

A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared with Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor

20110117HYPERCHOLESTEROLEMIA3

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects with Heterozygous Familial Hypercholesterolemia

20110231HYPERCHOLESTEROLEMIA2

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Stable Statin Therapy in Japanese Subjects With Hypercholesterolemia

20110233HYPERCHOLESTEROLEMIA2

A Two Part, Phase 2/3 Study to Assess the Safety and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

20120122HYPERCHOLESTEROLEMIA3

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Japanese Subjects With Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia

20120348HYPERCHOLESTEROLEMIA3

A multi-center, randomized study in patients with primary hypercholesterolemia and mixed dyslipidemia to assess users' ability to administer a full dose of AMG 145 in home-use using either a pre-filled syringe or an autoinjector device AMG 145

20120356HYPERCHOLESTEROLEMIA3

A multi-center, randomized study in patients with primary hypercholesterolemia and mixed dyslipidemia to assess patients' ability to self administer a full dose of AMG 145 in a non-clinic setting

20140213HYPERCHOLESTEROLEMIA1a

Phase I, Open-label, Single-dose Study of Evolocumab (AMG 145) Administered Subcutaneously to Subjects with Hyperlipidemia on Stable Doses of a Statin with Normal Renal Function or Stage 4 Renal Impairment or Stage 5 Renal Impairment Receiving Hemodialysis