79. 家族性高コレステロール血症(ホモ接合体)
[臨床試験数:128,薬物数:105(DrugBank:29),標的遺伝子数:8,標的パスウェイ数:15

Searched query = "Homozygous familial hypercholesterolemia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
22 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003170-13-AT
(EUCTR)
23/07/201911/02/2019Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
121Phase 3United States;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands;Japan
2EUCTR2017-003170-13-GR
(EUCTR)
01/02/201914/01/2019Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
121Phase 3United States;Czechia;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands;Japan
3EUCTR2017-003170-13-CZ
(EUCTR)
17/12/201811/10/2018Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
121Phase 3United States;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands;Japan
4EUCTR2017-002297-39-SI
(EUCTR)
25/09/201820/06/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Norway;Netherlands
5EUCTR2017-002297-39-NO
(EUCTR)
19/09/201815/05/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 3United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-002297-39-BG
(EUCTR)
11/09/201831/07/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway
7EUCTR2017-002297-39-AT
(EUCTR)
04/09/201807/06/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
50Phase 3Austria;United States;Taiwan;Slovenia;Spain;Turkey;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway
8EUCTR2017-002297-39-DK
(EUCTR)
03/09/201804/06/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Trade Name: Praluent
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway
9NCT03510715
(ClinicalTrials.gov)
August 31, 201818/4/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Homozygous Familial HypercholesterolemiaHypercholesterolemiaDrug: Alirocumab SAR236553 (REGN727);Drug: Rosuvastatin;Drug: Ezetimibe;Drug: Cholestyramine;Drug: Nicotinic acid;Drug: Fenofibrate;Drug: Omega-3 fatty acids;Drug: Atorvastatin;Drug: Simvastatin;Drug: Fluvastatin;Drug: Pravastatin;Drug: LovastatinSanofiRegeneron PharmaceuticalsCompleted8 Years17 YearsAll18Phase 3Brazil;Canada;Denmark;Mexico;Netherlands;Russian Federation;Slovenia;Spain;Taiwan;Turkey;Austria;France;Italy;Norway;United States
10EUCTR2017-002297-39-ES
(EUCTR)
28/08/201809/07/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Sanofi-Aventis Recherche & DéveloppementNULLNot Recruiting Female: yes
Male: yes
50Phase 3United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Norway;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-002297-39-FR
(EUCTR)
13/07/201816/05/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Sanofi-Aventis Recherche & DéveloppementNULLNot Recruiting Female: yes
Male: yes
50Phase 3United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Norway;Netherlands
12EUCTR2017-002297-39-NL
(EUCTR)
02/07/201816/05/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway
13EUCTR2017-002297-39-IT
(EUCTR)
26/06/201823/05/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway
14EUCTR2017-001388-19-GR
(EUCTR)
02/05/201802/04/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
65Phase 3United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Netherlands;Germany;Japan
15EUCTR2017-001388-19-AT
(EUCTR)
23/03/201830/01/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
57Phase 3United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-000351-95-DE
(EUCTR)
13/12/201717/08/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000012386;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 3France;United States;Czech Republic;Greece;Canada;Ukraine;Turkey;Austria;South Africa;Germany;Italy
17EUCTR2017-000351-95-GR
(EUCTR)
08/11/201719/10/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
54Phase 3Germany;France;United States;Czech Republic;Canada;Greece;Ukraine;Turkey;Austria;South Africa;Italy
18EUCTR2017-000351-95-AT
(EUCTR)
03/10/201722/08/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Regeneron Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
54Phase 3France;United States;Czech Republic;Greece;Canada;Ukraine;Turkey;Austria;South Africa;Germany;Italy
19NCT03156621
(ClinicalTrials.gov)
October 3, 201715/5/2017Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Homozygous Familial HypercholesterolemiaHomozygous Familial HypercholesterolemiaDrug: Alirocumab;Drug: PlaceboRegeneron PharmaceuticalsSanofiCompleted18 YearsN/AAll69Phase 3United States;Austria;Canada;Czechia;France;Germany;Greece;Italy;Japan;South Africa;Taiwan;Turkey;Ukraine
20EUCTR2017-000351-95-FR
(EUCTR)
18/07/201723/06/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
54Phase 3United States;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Italy;France;Denmark;South Africa;Tunisia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2017-001388-19-CZ
(EUCTR)
01/02/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
57Phase 3United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
22EUCTR2017-000351-95-CZ
(EUCTR)
28/07/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000012386;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
54Phase 3Serbia;Portugal;United States;Slovenia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Italy;United Kingdom;Czech Republic;Canada;Poland;Belgium;Croatia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Tunisia;Sweden