Bardoxolone methyl 20 mg ( DrugBank: Bardoxolone methyl, Bardoxolone )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
67多発性嚢胞腎6

67. 多発性嚢胞腎


臨床試験数 : 216 薬物数 : 219 - (DrugBank : 50) / 標的遺伝子数 : 39 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004651-20-GB
(EUCTR)
13/02/202007/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 10 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 20 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 15 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;France;Czech Republic;Spain;Belgium;Australia;Germany;Italy;United Kingdom
2EUCTR2018-004651-20-DE
(EUCTR)
20/01/202007/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 10 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 20 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 15 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
850Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy;Japan
3EUCTR2018-004651-20-CZ
(EUCTR)
12/12/201923/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 10 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 20 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 15 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy;Japan
4EUCTR2018-004651-20-IT
(EUCTR)
20/11/201905/01/2021A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: [RTA 402]
INN or Proposed INN: Bardoxolone Metile
Other descriptive name: Bardoxolone methyl
Product Name: Bardoxolone methyl 10 mg
Product Code: [RTA 402]
INN or Proposed INN: bardoxolone methyl
Other descriptive name: bardoxolone methyl
Product Name: Bardoxolone methyl 20 mg
Product Code: [RTA 402]
INN or Proposed INN: Bardoxolone methyl
Other descriptive name: Bardoxolone methyl
Product Name: Bardoxolone methyl 15 mg
Product Code: [RTA 402]
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: Bardoxolone methyl
REATA PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Italy
5EUCTR2018-004651-20-ES
(EUCTR)
19/11/201904/09/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 10 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 20 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 15 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Belgium;Spain;Australia;Germany;Italy;United Kingdom
6EUCTR2018-004651-20-BE
(EUCTR)
14/10/201929/08/2019A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Polycystic Kidney DiseaseA Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease - FALCON Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone methyl 5 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 10 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 20 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone methyl 15 mg
Product Code: RTA 402
INN or Proposed INN: Bardoxolone Methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3France;United States;Czechia;Czech Republic;Spain;Belgium;Australia;Germany;United Kingdom;Japan;Italy