Act-385781a    (DrugBank: -)

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16

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.
16 / 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
1JPRN-JapicCTI-142722
01/1/201527/11/2014ACT-385781A extension study for PAH pediatric patientsOpen-label, long-term, efficacy, safety, and tolerability extension study using ACT-385781A in the treatment of Japanese children with pulmonary arterial hypertension who completed the AC-066A308 study. Pulmonary arterial hypertension (PAH)Intervention name : ACT-385781A
INN of the intervention : epoprostenol
Dosage And administration of the intervention : continuous intravenous infusion
Actelion Pharmaceuticals Japan Ltd.NULL14BOTH3Phase 3NULL
2JPRN-JapicCTI-142721
01/9/201427/11/2014ACT-385781A for PAH pediatric patientsProspectiove, single-arm, Open-label, multi-center study to assess the efficacy, safety, and tolerability of ACT-385781A in Japanese children with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH)Intervention name : ACT-385781A
INN of the intervention : epoprostenol
Dosage And administration of the intervention : continuous intravenous infusion
Control intervention name : null
Actelion Pharmaceuticals Japan Ltd.NULL14BOTH3Phase 3NULL
3JPRN-JapicCTI-132142
01/4/201303/06/2013ACT-385781A PAH Post-marketing studyA Post-marketing, Open-label-study ACT-385781A in patients with pulmonary arterial hypertension Pulmonary arterial hypertension (PAH)Intervention name : ACT-385781A
INN of the intervention : Epoprostenol
Dosage And administration of the intervention : A commercially available epoprostenol sodium preparation will be switched to the study drug at the same dose
Actelion Pharmaceuticals Japan Ltd.NULL20BOTH5Phase 4NULL
4EUCTR2010-018320-10-ES
(EUCTR)
26/12/201121/11/2011An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH)Extension del estudio AC-066A301, abierta, para investigar la seguridad y la tolerabilidad de ACT-385781A en pacientes con Hipertension Arterial Pulmonar (HAP) - EPITOME-2 Extension Hipertension Arterial Pulmonar
MedDRA version: 14.0;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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40France;Canada;Belgium;Spain;Netherlands;Italy
5EUCTR2010-018320-10-IT
(EUCTR)
04/11/201101/03/2012An extension of study AC-066A301 to investigate safety and tolerabilityof the study medication (epoprostenol for injection)Estensione in aperto dello studio AC-066A301 per valutare la sicurezza e la tollerabilita' dell’ACT-385781A nei pazienti affetti da ipertensione arteriosa polmonare (IAP) - EPITOME-2 Extension Pulmonary Arterial Hypertension
MedDRA version: 14.1;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]
Trade Name: Epoprostenolo per iniezione
INN or Proposed INN: EPOPROSTENOL SODIUM
Other descriptive name: NA
Trade Name: Epoprostenolo per iniezione
INN or Proposed INN: EPOPROSTENOL SODIUM
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
40Canada;Spain;Belgium;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-JapicCTI-122017
01/8/201103/12/2012ACT-385781A PAHOpen-label study ACT-385781A in patients with pulmonary arterial hypertension Pulmonary arterial hypertension (PAH)Intervention name : ACT-385781A
INN of the intervention : epoprostenol
Dosage And administration of the intervention : Continuous intravenous infusion
Actelion Pharmaceuticals Japan Ltd.NULL20BOTH10Phase 3NULL
7EUCTR2010-018322-40-NL
(EUCTR)
11/07/201119/07/2011A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
35Phase 3bNetherlands;Belgium;France;Spain;Italy
8EUCTR2010-018320-10-NL
(EUCTR)
11/07/201112/05/2011An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension Pulmonary Arterial Hypertension
MedDRA version: 14.1;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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40France;Canada;Belgium;Spain;Netherlands;Italy
9EUCTR2010-018322-40-ES
(EUCTR)
17/06/201103/11/2011Estudio de investigación clínica para evaluar la seguridad de cambiar el Flolan por un nuevo fármaco llamado Epoprostenol-Actelion en pacientes que padecen hipertensión arterial pulmonarEstudio de fase 3b multicéntrico, de una única rama, abierto para evaluar los efectos de cambiar de Flolan® a ACT-385781A en pacientes con hipertensión arterial pulmonar // A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 Hipertensión Arterial Pulmonar (HAP)
MedDRA version: 14.0;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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODICO
Other descriptive name: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODICO
Other descriptive name: EPOPROSTENOL SODIUM
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
35Phase 3bFrance;Canada;Belgium;Spain;Netherlands;Italy
10NCT01470144
(ClinicalTrials.gov)
June 1, 201128/10/2011Epoprostenol for Injection in Patients With Pulmonary Arterial HypertensionAn Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: EpoprostenolActelionChiltern International Ltd.;Effi-statCompletedN/AN/AAll41Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT01431716
(ClinicalTrials.gov)
March 20117/9/2011Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial HypertensionA Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: EFI/ACT-385781AActelionNULLCompleted18 YearsN/AAll42Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
12EUCTR2010-018320-10-BE
(EUCTR)
02/07/201013/04/2010An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension Pulmonary Arterial Hypertension
MedDRA version: 14.1;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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40France;Canada;Spain;Belgium;Netherlands;Italy
13EUCTR2010-018322-40-BE
(EUCTR)
02/07/201007/04/2010A clinical research study to evaluate the safety of changing from Flolan to a new drug called Epoprostenol-Actelion in patients suffering from pulmonary arterial hypertensionA Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 Pulmonary Arterial Hypertension
MedDRA version: 14.1;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]
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
Trade Name: Epoprostenol for injection
Product Name: Epoprostenol for injection
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 3France;Canada;Spain;Belgium;Netherlands;Italy
14EUCTR2010-018322-40-FR
(EUCTR)
20/05/201029/03/2010A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Epoprostenol-Actelion
Product Name: Epoprostenol-Actelion
Product Code: ACT-385781A
INN or Proposed INN: EPOPROSTENOL SODIUM
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3bNetherlands;Belgium;France;Spain;Italy
15NCT01105117
(ClinicalTrials.gov)
May 201015/4/2010Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNULLCompleted18 Years65 YearsAll2Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01105091
(ClinicalTrials.gov)
March 201015/4/2010Epoprostenol for Injection in Pulmonary Arterial HypertensionA Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNULLCompleted18 Years65 YearsAll30Phase 4United States