ZAMICASTAT ( DrugBank: Zamicastat )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症12

86. 肺動脈性肺高血圧症


臨床試験数 : 1,181 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002796-18-IT
(EUCTR)
28/11/201929/01/2021To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease - Safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: zamicastat
Product Code: [BIA-5-1058]
INN or Proposed INN: zamicastat
BIAL-Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
2EUCTR2018-002448-10-DE
(EUCTR)
08/11/201917/08/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2Portugal;France;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy
3EUCTR2018-002448-10-IT
(EUCTR)
29/10/201901/02/2021Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: zamicastat
Product Code: [BIA 5-1058]
INN or Proposed INN: zamicastat
BIAL-Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
4EUCTR2018-002796-18-PT
(EUCTR)
30/07/201930/10/2018To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA-5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2Portugal;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy
5NCT04316143
(ClinicalTrials.gov)
June 6, 201918/3/2020Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAHAn Open-label, Multicentre Study to Evaluate Pharmacokinetics, Safety and Efficacy of Zamicastat as Adjunctive Therapy in Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ZamicastatBial - Portela C S.A.NULLCompleted18 Years65 YearsAll33Phase 2Spain
6EUCTR2018-002796-18-GB
(EUCTR)
12/03/201919/06/2019To study the safety and how effective Long-term Zamicastat treatment is for Pulmonary Arterial HypertensionAn open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease. - Safety and efficacy of BIA 5-1058 in PAH Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: Zamicastat
Bial - Portela & Ca, S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2Portugal;Belgium;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom
7EUCTR2018-002448-10-GB
(EUCTR)
11/02/201919/06/2019Multi centre study to assess the safety, effective and movement of Zamicastat within the body when given to a patient with pulmonary arterial hypertension as an additional medication.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmcokinetics, safety and efficacy of BIA-5-1058 in PAH Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
Bial - Portela & Ca, S.ANULLNot RecruitingFemale: yes
Male: yes
32Phase 2Portugal;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom
8EUCTR2018-002796-18-ES
(EUCTR)
17/01/201916/11/2018To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA-5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;Spain;Ukraine;Austria;United Kingdom
9EUCTR2018-002796-18-AT
(EUCTR)
20/12/201806/11/2018To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA-5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
10EUCTR2018-002448-10-PT
(EUCTR)
26/11/201804/09/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Portugal;Spain;Belgium;Ukraine;Austria;Netherlands;Germany;United Kingdom;Italy
11EUCTR2018-002448-10-ES
(EUCTR)
21/11/201809/10/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria
12EUCTR2018-002448-10-AT
(EUCTR)
31/10/201808/08/2018Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Zamicastat
Product Code: BIA 5-1058
INN or Proposed INN: ZAMICASTAT
Other descriptive name: BIA 5-1058
Bial - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy