Bia 5-1058    (DrugBank: BIA)

2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病0
86肺動脈性肺高血圧症11

6. パーキンソン病 [臨床試験数:2,123,薬物数:2,046(DrugBank:324),標的遺伝子数:183,標的パスウェイ数:198
Searched query = "Parkinson disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: . Trials are sorted by Date_enrollment from most recent to oldest in the table.
0 / 2,123 trial found

86. 肺動脈性肺高血圧症 [臨床試験数:1,083,薬物数:667(DrugBank:122),標的遺伝子数:98,標的パスウェイ数:185
Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
11 / 1,083 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002448-10-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;France;Belgium;Spain;Ukraine;Austria;Germany;Italy;United Kingdom
2EUCTR2018-002796-18-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom;Italy
3NCT04316143
(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.NULLRecruiting18 Years65 YearsAll32Phase 2Spain
4EUCTR2018-002796-18-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
5EUCTR2018-002448-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-002796-18-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
7EUCTR2018-002448-10-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Portugal;Spain;Belgium;Ukraine;Austria;Netherlands;Germany;United Kingdom;Italy
8EUCTR2018-002448-10-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
9EUCTR2018-002448-10-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Portugal;Spain;Ukraine;Austria;Germany;United Kingdom;Italy
10NCT03708146
(ClinicalTrials.gov)
May 28, 201812/10/2018Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of BIA 5 1058 in Healthy VolunteersCardiovascular Disease+Pulmonary Disease;Pulmonary Arterial HypertensionDrug: BIA 5-1058;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years55 YearsAll157Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03489005
(ClinicalTrials.gov)
April 9, 201829/3/2018Effect of BIA 5 1058 on Cardiac RepolarizationA Randomized, Double-blind, Placebo-controlled and Open-label, Active Controlled, 4 Period Crossover Trial to Evaluate the Effect of BIA 5 1058 on Cardiac Repolarization in Healthy Adult Males and Females Under Fed ConditionsCardiovascular Disease;Pulmonary Arterial Hypertension;Heart FailureDrug: BIA 5-1058;Drug: Placebo Oral Tablet;Drug: Moxifloxacin 400 mgBial - Portela C S.A.CovanceCompleted18 Years55 YearsAll49Phase 1United Kingdom