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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR PRALUENT


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All Clinical Trials for PRALUENT

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01507831 ↗ 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) Completed Regeneron Pharmaceuticals Phase 3 2012-01-01 Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: - To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. - To evaluate the effects of alirocumab on other lipid parameters.
NCT01507831 ↗ 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) Completed Sanofi Phase 3 2012-01-01 Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: - To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. - To evaluate the effects of alirocumab on other lipid parameters.
NCT01576484 ↗ Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) Completed Sanofi Phase 2 2012-02-28 The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).
NCT01576484 ↗ Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) Completed Regeneron Pharmaceuticals Phase 2 2012-02-28 The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).
NCT01617655 ↗ Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) Completed Regeneron Pharmaceuticals Phase 3 2012-06-01 Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points - To evaluate the effects of alirocumab on other lipid parameters - To evaluate the safety and tolerability of alirocumab
NCT01617655 ↗ Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) Completed Sanofi Phase 3 2012-06-01 Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points - To evaluate the effects of alirocumab on other lipid parameters - To evaluate the safety and tolerability of alirocumab
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PRALUENT

Condition Name

Condition Name for PRALUENT
Intervention Trials
Hypercholesterolemia 11
Hypercholesterolaemia 4
Atherosclerosis 3
Sepsis 2
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Condition MeSH

Condition MeSH for PRALUENT
Intervention Trials
Hypercholesterolemia 17
Hyperlipoproteinemia Type II 8
Atherosclerosis 5
Dyslipidemias 3
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Clinical Trial Locations for PRALUENT

Trials by Country

Trials by Country for PRALUENT
Location Trials
United States 239
United Kingdom 27
South Africa 23
Canada 13
Israel 10
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Trials by US State

Trials by US State for PRALUENT
Location Trials
Ohio 13
Missouri 12
Florida 12
California 12
Texas 12
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Clinical Trial Progress for PRALUENT

Clinical Trial Phase

Clinical Trial Phase for PRALUENT
Clinical Trial Phase Trials
Phase 4 9
Phase 3 9
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for PRALUENT
Clinical Trial Phase Trials
Completed 17
Active, not recruiting 3
Terminated 3
[disabled in preview] 4
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Clinical Trial Sponsors for PRALUENT

Sponsor Name

Sponsor Name for PRALUENT
Sponsor Trials
Regeneron Pharmaceuticals 22
Sanofi 18
Chang Gung University 1
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Sponsor Type

Sponsor Type for PRALUENT
Sponsor Trials
Industry 41
Other 17
U.S. Fed 1
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