Placebo (for alirocumab)

DRUG13 trials

Conditions

HypercholesterolaemiaHypercholesterolemia

Phase 2

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia

CompletedNCT01288469

SanofiHypercholesterolemia

Start: 2011-01-31End: 2011-09-30Updated: 2015-09-24

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

CompletedNCT01288443

SanofiHypercholesterolemia

Start: 2011-01-31End: 2011-12-31Updated: 2015-09-24

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan

CompletedNCT01812707

SanofiHypercholesterolemia

Start: 2013-03-31End: 2014-01-31Updated: 2016-10-04

Phase 3

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

CompletedNCT01507831

SanofiHypercholesterolemia

Start: 2012-01-31End: 2014-11-30Updated: 2015-12-22

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

CompletedNCT01617655

SanofiHypercholesterolaemia

Start: 2012-06-30End: 2015-01-31Updated: 2016-10-04

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

CompletedNCT01623115

SanofiHypercholesterolemia

Start: 2012-07-31End: 2014-12-31Updated: 2016-02-08

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

CompletedNCT01644175

SanofiHypercholesterolemia

Start: 2012-07-31End: 2014-04-30Updated: 2015-11-06

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

CompletedNCT01644188

SanofiHypercholesterolemia

Start: 2012-08-31End: 2015-07-31Updated: 2016-08-04

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia

CompletedNCT01644474

SanofiHypercholesterolemia

Start: 2012-07-31End: 2013-07-31Updated: 2015-11-06

Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

CompletedNCT01926782

Regeneron PharmaceuticalsHypercholesterolemia

Start: 2013-09-30End: 2015-04-30Updated: 2017-03-21

Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)

CompletedNCT02023879

SanofiHypercholesterolemia

Start: 2013-12-16End: 2017-06-30Updated: 2018-07-27

Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)

CompletedNCT02107898

SanofiHypercholesterolemia

Start: 2014-03-31End: 2015-09-30Updated: 2016-10-04

Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

CompletedNCT02289963

SanofiHypercholesterolemia

Start: 2015-01-31End: 2016-04-30Updated: 2017-06-26

2020-07-257 citations

Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia

JAMA Cardiology2020-07-01178 citations

A subanalysis of Taiwanese patients from ODYSSEY South Korea and Taiwan study evaluating the efficacy and safety of alirocumab.

2019-04-017 citations

Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia.

2017-09-0438 citations

Safety of Very Low Low-Density Lipoprotein Cholesterol Levels With Alirocumab

Journal of the American College of Cardiology2017-01-30193 citations

Reductions in Atherogenic Lipids and Major Cardiovascular Events

Circulation2016-10-25128 citations

Efficacy and Safety of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia and LDL-C of 160 mg/dl or Higher.

2016-10-01167 citations

Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study

Journal of the American Heart Association2016-09-01100 citations

A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I.

2016-08-3193 citations

Relationship Between Low‐Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid‐Lowering Strategies

Journal of the American Heart Association2016-06-1142 citations

Effect of alirocumab on specific lipoprotein non-high-density lipoprotein cholesterol and subfractions as measured by the vertical auto profile method: analysis of 3 randomized trials versus placebo.

2016-02-1336 citations

Effect of PCSK9 Inhibition by Alirocumab on Lipoprotein Particle Concentrations Determined by Nuclear Magnetic Resonance Spectroscopy

Journal of the American Heart Association2015-10-2953 citations

ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia

European Heart Journal2015-09-01531 citations

Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events

New England Journal of Medicine2015-03-152260 citations

Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: The ODYSSEY COMBO I study.

2015-03-13255 citations

Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial

European Heart Journal2015-02-16394 citations

ODYSSEY FH I and FH II: Alirocumab Significantly Improves Cholesterol Levels in Patients with HeFH

MD Conference Express2014-10-01

ODYSSEY COMBO II: Alirocumab Significantly Improves Cholesterol Levels in Patients with High CV Risk

MD Conference Express2014-10-01

Efficacy and Safety of Alirocumab as Add‐on Therapy in High–Cardiovascular‐Risk Patients With Hypercholesterolemia Not Adequately Controlled With Atorvastatin (20 or 40 mg) or Rosuvastatin (10 or 20 mg): Design and Rationale of the <scp>ODYSSEY OPTIONS</scp> Studies

Clinical Cardiology2014-09-3045 citations

Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials.

2014-09-2042 citations

5 more papers not shown

Placebo (for alirocumab)

Sponsors

Conditions

Phase 2

Phase 3

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