BIA 5-1058 ( DrugBank: BIA )


1 disease
IDDisease name (Link within this page)Number of trials
86Pulmonary arterial hypertension20

86. Pulmonary arterial hypertension


Clinical trials : 1,181 Drugs : 701 - (DrugBank : 126) / Drug target genes : 105 - Drug target pathways : 192
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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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
13NCT03708146
(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
14NCT03489005
(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
15NCT04994860
(ClinicalTrials.gov)
March 22, 201829/7/2021Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of SildenafilAn Open-Label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Sildenafil in Healthy Subjects Under Fasting ConditionsPulmonary Arterial HypertensionDrug: BIA 5-1058;Drug: SildenafilBial - Portela C S.A.NULLCompleted18 Years45 YearsAll20Phase 1Germany
16NCT04994119
(ClinicalTrials.gov)
February 23, 201829/7/2021Effect of BIA 5-1058 400 mg on Warfarin PharmacokineticsAn Open-label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5 1058 400 mg on Warfarin Pharmacokinetics in Healthy Subjects Under Fasting ConditionsPulmonary Arterial HypertensionDrug: BIA 5-1058;Drug: WarfarinBial - Portela C S.A.NULLCompleted18 Years45 YearsAll26Phase 1Germany
17NCT04991207
(ClinicalTrials.gov)
February 6, 201828/7/2021Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of BosentanAn Open-label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5 1058 400 mg on the Steady State Pharmacokinetics of Bosentan in Healthy Subjects Under Fasting ConditionsPulmonary Arterial HypertensionDrug: BIA 5-1058;Drug: bosentanBial - Portela C S.A.NULLCompleted18 Years45 YearsAll44Phase 1Germany
18NCT04991181
(ClinicalTrials.gov)
March 31, 201728/7/2021Absorption, Distribution, Metabolism and Excretion of BIA 5-1058An Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion, Including the Mass Balance, of [14C] Labeled BIA 5-1058 and Metabolites Following a Single Oral Dose Administration in Healthy Male SubjectsPulmonary Arterial HypertensionDrug: 400 mg BIA 5-1058Bial - Portela C S.A.NULLCompleted18 Years65 YearsMale15Phase 1Netherlands
19NCT04991194
(ClinicalTrials.gov)
October 12, 201528/7/2021Effect of Age-gender on the Pharmacokinetic and Pharmacodynamic Profiles of BIA 5 1058Effect of Age-gender on the Pharmacokinetic and Pharmacodynamic Profiles of BIA 5 1058. An Open-label, Parallel Group, Multiple Dose 10-day Study.Pulmonary Arterial HypertensionDrug: BIA 5-1058Bial - Portela C S.A.NULLTerminated18 YearsN/AAll61Phase 1NULL
20NCT04991155
(ClinicalTrials.gov)
July 20, 201528/7/2021Effect of Food on BIA 5-1058Effect of Food on BIA 5-1058 Bioavailability in Healthy SubjectsPulmonary Arterial HypertensionDrug: BIA 5-1058Bial - Portela C S.A.NULLCompleted18 Years45 YearsAll57Phase 1NULL