Placebo to Evolocumab

DRUG11 trials

Sponsors

Amgen

Conditions

HypercholesterolemiaHyperlipidemiaHyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular EventsMixed DyslipidemiaPrimary Hyperlipidemia and Mixed DyslipidemiaType 2 Diabetes

Phase 2

Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

CompletedNCT01375777

AmgenHyperlipidemia

Start: 2011-07-06End: 2012-03-02Updated: 2022-11-08

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

CompletedNCT01375764

AmgenHyperlipidemia

Start: 2011-07-28End: 2012-05-08Updated: 2022-11-07

LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

CompletedNCT01380730

AmgenHyperlipidemia

Start: 2011-07-01End: 2012-04-05Updated: 2022-11-15

Phase 3

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

CompletedNCT01763905

AmgenHyperlipidemia

Start: 2013-01-24End: 2013-11-19Updated: 2020-07-20

LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2

CompletedNCT01763866

AmgenHyperlipidemia

Start: 2013-01-15End: 2013-12-04Updated: 2022-11-08

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

CompletedNCT01763827

AmgenHyperlipidemia

Start: 2013-01-21End: 2013-10-29Updated: 2022-11-08

Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

CompletedNCT01953328

AmgenHyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events

Start: 2013-10-31End: 2014-06-30Updated: 2015-12-23

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3

CompletedNCT01984424

AmgenHyperlipidemia

Start: 2013-12-10End: 2017-11-21Updated: 2018-11-29

Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody

CompletedNCT02189837

AmgenPrimary Hyperlipidemia and Mixed Dyslipidemia

Start: 2014-07-08End: 2015-03-05Updated: 2018-10-03

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4

CompletedNCT02634580

AmgenHypercholesterolemia

Start: 2016-02-27End: 2018-05-26Updated: 2020-11-10

Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

CompletedNCT02739984

AmgenHypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes

Start: 2016-05-17End: 2017-08-03Updated: 2018-08-31

Related Papers

Quantification of LDL-Cholesterol Corrected for Molar Concentration of Lipoprotein(a)

Cardiovascular Drugs and Therapy2022-11-2617 citations

Effect of alirocumab on individuals with type 2 diabetes, high triglycerides, and low high-density lipoprotein cholesterol

Cardiovascular Diabetology2020-02-0831 citations

Evolocumab vs. Ezetimibe in Statin-Intolerant Hyperlipidemic Japanese Patients: Phase 3 GAUSS-4 Trial

Journal of Atherosclerosis and Thrombosis2019-11-2028 citations

Efficacy and safety of evolocumab in individuals with type 2 diabetes mellitus: primary results of the randomised controlled BANTING study.

2019-04-0553 citations

Controlled study of the effect of proprotein convertase subtilisin-kexin type 9 inhibition with evolocumab on lipoprotein(a) particle kinetics

European Heart Journal2018-03-02144 citations

Factorial Effects of Evolocumab and Atorvastatin on Lipoprotein Metabolism

Circulation2016-12-1092 citations

Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance

JAMA2016-04-03502 citations

Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting.

2016-03-0918 citations

Effect of Evolocumab or Ezetimibe Added to Moderate- or High-Intensity Statin Therapy on LDL-C Lowering in Patients With Hypercholesterolemia

JAMA2014-05-13493 citations

Monoclonal Antibody Reduces LDL-C in Presence of Statin (LAPLACE-2)

MD Conference Express2014-05-01

Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab.

2014-03-30392 citations

Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab.

2014-03-29308 citations

Intolerance to statins and response to PCSK9 inhibition with AMG 145

European Heart Journal2013-08-021 citations

Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial.

2012-12-01343 citations

Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study.

2012-11-06326 citations

Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study.

2012-11-06270 citations

Design and rationale of the LAPLACE-TIMI 57 trial: a phase II, double-blind, placebo-controlled study of the efficacy and tolerability of a monoclonal antibody inhibitor of PCSK9 in subjects with hypercholesterolemia on background statin therapy.

2012-06-1934 citations