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Last Updated: July 23, 2021

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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.
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
NCT01623115 ↗ 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 Completed Regeneron Pharmaceuticals Phase 3 2012-07-01 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 8
Hypercholesterolaemia 4
Atherosclerosis 3
Myocardial Infarction 2
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Condition MeSH

Condition MeSH for PRALUENT
Intervention Trials
Hypercholesterolemia 13
Hyperlipoproteinemia Type II 6
Atherosclerosis 4
Dyslipidemias 3
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Clinical Trial Locations for PRALUENT

Trials by Country

Trials by Country for PRALUENT
Location Trials
United States 148
United Kingdom 20
Canada 7
France 6
Israel 6
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Trials by US State

Trials by US State for PRALUENT
Location Trials
Texas 10
Florida 8
California 8
Ohio 7
North Carolina 7
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Clinical Trial Progress for PRALUENT

Clinical Trial Phase

Clinical Trial Phase for PRALUENT
Clinical Trial Phase Trials
Phase 4 8
Phase 3 8
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for PRALUENT
Clinical Trial Phase Trials
Recruiting 7
Not yet recruiting 5
Completed 5
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Clinical Trial Sponsors for PRALUENT

Sponsor Name

Sponsor Name for PRALUENT
Sponsor Trials
Regeneron Pharmaceuticals 18
Sanofi 15
Assaf-Harofeh Medical Center 1
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Sponsor Type

Sponsor Type for PRALUENT
Sponsor Trials
Industry 34
Other 13
U.S. Fed 1
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Moodys
Colorcon
Harvard Business School
Express Scripts

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