ACU-4429 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
301黄斑ジストロフィー7

301. 黄斑ジストロフィー


臨床試験数 : 46 薬物数 : 42 - (DrugBank : 11) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 67
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003498-82-DK
(EUCTR)
11/06/201917/12/2018Evaluation of Emixustat for the Treatment of Stargardt DiseaseA Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease - The SeaSTAR Study (Safety and efficacy of EmixustAt in STARgardt disease) Stargardt Disease
MedDRA version: 20.1;Level: PT;Classification code 10062766;Term: Stargardt's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Acucela Inc.NULLNot RecruitingFemale: yes
Male: yes
194Phase 3United States;France;Canada;Spain;Brazil;Denmark;South Africa;Netherlands;Germany;United Kingdom;Italy
2EUCTR2018-003498-82-IT
(EUCTR)
29/05/201913/01/2021Evaluation of Emixustat for the Treatment of Stargardt DiseaseA Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease - The SeaSTAR Study (Safety and efficacy of EmixustAt in STARgardt disease) A Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease
MedDRA version: 20.1;Level: PT;Classification code 10062766;Term: Stargardt's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: Emixustat hydrochloride
Product Code: [ACU-4429]
INN or Proposed INN: Emixustat hydrochloride
Product Name: Emixustat hydrochloride
Product Code: [ACU-4429]
INN or Proposed INN: Emixustat hydrochloride
Acucela Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
162Phase 3France;United States;Canada;Spain;Brazil;Denmark;South Africa;Netherlands;Germany;United Kingdom;Italy
3EUCTR2018-003498-82-NL
(EUCTR)
27/05/201928/01/2019Evaluation of Emixustat for the Treatment of Stargardt DiseaseA Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease - The SeaSTAR Study (Safety and efficacy of EmixustAt in STARgardt disease) Stargardt Disease
MedDRA version: 20.1;Level: PT;Classification code 10062766;Term: Stargardt's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Acucela Inc.NULLNot RecruitingFemale: yes
Male: yes
194Phase 3France;United States;Canada;Spain;Brazil;Denmark;South Africa;Germany;Netherlands;United Kingdom;Italy
4EUCTR2018-003498-82-ES
(EUCTR)
26/04/201922/01/2019Evaluation of Emixustat for the Treatment of Stargardt DiseaseA Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease - The SeaSTAR Study (Safety and efficacy of EmixustAt in STARgardt disease) Stargardt Disease
MedDRA version: 20.1;Level: PT;Classification code 10062766;Term: Stargardt's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Acucela Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
162 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Brazil;Spain;Denmark;South Africa;Netherlands;Germany;Italy;United Kingdom
5EUCTR2018-003498-82-GB
(EUCTR)
18/03/201906/12/2018Evaluation of Emixustat for the Treatment of Stargardt DiseaseA Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease - The SeaSTAR Study (Safety and efficacy of EmixustAt in STARgardt disease) Stargardt Disease
MedDRA version: 20.1;Level: PT;Classification code 10062766;Term: Stargardt's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Acucela Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
194Phase 3United States;France;Canada;Spain;Brazil;Denmark;South Africa;Netherlands;Germany;Italy;United Kingdom
6EUCTR2018-003498-82-DE
(EUCTR)
21/12/2018Evaluation of Emixustat for the Treatment of Stargardt DiseaseA Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease - The SeaSTAR Study (Safety and efficacy of EmixustAt in STARgardt disease) Stargardt Disease
MedDRA version: 20.1;Level: PT;Classification code 10062766;Term: Stargardt's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Acucela Inc.NULLNot RecruitingFemale: yes
Male: yes
194Phase 3United States;France;Canada;Spain;Brazil;Denmark;South Africa;Netherlands;Germany;United Kingdom;Italy
7EUCTR2018-003498-82-FR
(EUCTR)
14/12/2018Evaluation of Emixustat for the Treatment of Stargardt DiseaseA Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease - The SeaSTAR Study (Safety and efficacy of EmixustAt in STARgardt disease) Stargardt Disease
MedDRA version: 20.1;Level: PT;Classification code 10062766;Term: Stargardt's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Product Name: Emixustat hydrochloride
Product Code: ACU-4429
INN or Proposed INN: Emixustat hydrochloride
Other descriptive name: EMIXUSTAT HYDROCHLORIDE (ACU-4429)
Acucela Inc.NULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;France;Canada;Spain;Brazil;Denmark;South Africa;Netherlands;Germany;United Kingdom;Italy