301. 黄斑ジストロフィー Macular dystrophy Clinical trials / Disease details


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

  
8 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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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
6NCT03033108
(ClinicalTrials.gov)
January 201720/1/2017Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt DiseaseA Phase 2a Multicenter, Randomized, Masked Study Evaluating the Pharmacodynamics of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt DiseaseStargardt Disease;Macular AtrophyDrug: EmixustatKubota Vision Inc.NULLCompleted18 YearsN/AAll23Phase 2United States
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
8EUCTR2018-003498-82-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