301. 黄斑ジストロフィー Macular dystrophy Clinical trials / Disease details
臨床試験数 : 45 / 薬物数 : 46 - (DrugBank : 12) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 67
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-003498-82-DK (EUCTR) | 11/06/2019 | 17/12/2018 | Evaluation of Emixustat for the Treatment of 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 - 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 194 | Phase 3 | United States;France;Canada;Spain;Brazil;Denmark;South Africa;Netherlands;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2018-003498-82-IT (EUCTR) | 29/05/2019 | 13/01/2021 | Evaluation of Emixustat for the Treatment of 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 - 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | Phase 3 | France;United States;Canada;Spain;Brazil;Denmark;South Africa;Netherlands;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2018-003498-82-NL (EUCTR) | 27/05/2019 | 28/01/2019 | Evaluation of Emixustat for the Treatment of 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 - 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 194 | Phase 3 | France;United States;Canada;Spain;Brazil;Denmark;South Africa;Germany;Netherlands;United Kingdom;Italy | ||
| 4 | EUCTR2018-003498-82-ES (EUCTR) | 26/04/2019 | 22/01/2019 | Evaluation of Emixustat for the Treatment of 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 - 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. | NULL | Authorised-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): no | France;United States;Canada;Brazil;Spain;Denmark;South Africa;Netherlands;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2018-003498-82-GB (EUCTR) | 18/03/2019 | 06/12/2018 | Evaluation of Emixustat for the Treatment of 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 - 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 194 | Phase 3 | United States;France;Canada;Spain;Brazil;Denmark;South Africa;Netherlands;Germany;Italy;United Kingdom | ||
| 6 | NCT03772665 (ClinicalTrials.gov) | November 7, 2018 | 30/11/2018 | 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 | Stargardt Disease | Drug: Emixustat;Drug: Placebo | Kubota Vision Inc. | NULL | Active, not recruiting | 16 Years | N/A | All | 194 | Phase 3 | United States;Brazil;Canada;Denmark;France;Germany;Italy;Netherlands;South Africa;Spain;United Kingdom |
| 7 | NCT03033108 (ClinicalTrials.gov) | January 2017 | 20/1/2017 | Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease | A Phase 2a Multicenter, Randomized, Masked Study Evaluating the Pharmacodynamics of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease | Stargardt Disease;Macular Atrophy | Drug: Emixustat | Kubota Vision Inc. | NULL | Completed | 18 Years | N/A | All | 23 | Phase 2 | United States |
| 8 | EUCTR2018-003498-82-FR (EUCTR) | 14/12/2018 | Evaluation of Emixustat for the Treatment of 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 - 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. | NULL | NA | Female: yes Male: yes | 162 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Canada;Brazil;Spain;Denmark;South Africa;Netherlands;Germany;Italy;United Kingdom | |||
| 9 | EUCTR2018-003498-82-DE (EUCTR) | 21/12/2018 | Evaluation of Emixustat for the Treatment of 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 - 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. | NULL | NA | Female: yes Male: yes | 194 | Phase 3 | United States;France;Canada;Spain;Brazil;Denmark;South Africa;Netherlands;Germany;United Kingdom;Italy |