RTA 402 ( DrugBank: - )


3 diseases
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7
86肺動脈性肺高血圧症6
218アルポート症候群4

67. 多発性嚢胞腎


臨床試験数 : 221 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 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;Belgium;Spain;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
7EUCTR2018-004651-20-FR
(EUCTR)
11/09/201908/08/2019A 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 3Czech Republic;Belgium;United States;Denmark;Italy;United Kingdom;France;Australia;Germany;Spain

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-000196-24-GB
(EUCTR)
18/10/201628/11/2016A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
2EUCTR2016-000196-24-BE
(EUCTR)
17/10/201611/07/2016A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Reata Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
3EUCTR2016-000196-24-NL
(EUCTR)
10/10/201613/07/2016BADOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
4EUCTR2016-000196-24-CZ
(EUCTR)
30/08/201618/07/2016A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan
5EUCTR2016-000196-24-DE
(EUCTR)
11/08/201627/06/2016BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Philippines;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;Netherlands;Japan
6EUCTR2016-000196-24-ES
(EUCTR)
04/07/201601/06/2016A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSIONA STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION - CATALYST Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (WHO Group I CTD-PAH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester
Reata Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Chile;Israel;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;Germany;Japan

218. アルポート症候群


臨床試験数 : 30 薬物数 : 36 - (DrugBank : 15) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 46
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-004395-22-GB
(EUCTR)
28/03/201831/10/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Australia;Germany;United Kingdom
2EUCTR2016-004395-22-ES
(EUCTR)
24/01/201807/11/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2;Phase 3United States;France;Canada;Spain;Australia;Germany;United Kingdom
3EUCTR2016-004395-22-DE
(EUCTR)
19/12/201725/09/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2;Phase 3United States;France;Canada;Spain;Australia;Germany;United Kingdom
4EUCTR2016-004395-22-FR
(EUCTR)
04/12/201705/12/2017clinical study to evaluate the efficacy and safety of a new drug (Bardoxolone methyl) in the treatment of subjects with Alport syndromeA Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINAL Alport Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10001843;Term: Alport's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Bardoxolone Methyl
Product Code: RTA 402
INN or Proposed INN: bardoxolone methyl
Other descriptive name: BARDOXOLONE METHYL
Reata Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3United States;France;Canada;Spain;Australia;Germany;United Kingdom