Beraprost    (DrugBank: Beraprost)

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23

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.
23 / 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
1NCT03431649
(ClinicalTrials.gov)
April 1, 201729/7/2017Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in ChildrenEfficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart DefectPediatric Pulmonary HypertensionDrug: Beraprost Sodium;Drug: Sildenafil CitrateDr. Soetomo General HospitalNULLCompleted1 Year17 YearsAll40Phase 4Indonesia
2JPRN-UMIN000025176
2017/01/0115/12/2016Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. Pulmonary arterial hypertensionMedicine transition from beraprost to selexipag

In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed.
The maximum dose allowed is 1.6mg twice daily.
Hamamatsu University School of MedicineNULLOpen public recruiting16years-oldNot applicableMale and Female33Not selectedJapan
3NCT01966302
(ClinicalTrials.gov)
November 201315/10/2013Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH).Pulmonary Arterial HypertensionDrug: BPS-314d-MRLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLung Biotechnology PBCCompleted18 Years75 YearsAll1Phase 2United States
4NCT01908699
(ClinicalTrials.gov)
May 31, 201316/7/2013Beraprost-314d Added-on to Tyvaso® (BEAT)A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Beraprost Sodium 314d Modified Release Tablets;Drug: PlaceboLung Biotechnology PBCNULLCompleted18 Years80 YearsAll273Phase 3United States;Israel
5NCT01458236
(ClinicalTrials.gov)
November 201129/9/2011A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 InhibitorA Multinational, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 InhibitorPulmonary Arterial HypertensionDrug: Beraprost Sodium 314d Modified Release Tablets;Drug: PlaceboLung Biotechnology Inc.NULLWithdrawn18 Years80 YearsBoth0Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2009-014453-32-CZ
(EUCTR)
15/07/201011/02/2010NAAn open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients 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] - Respiratory Tract Diseases [C08]
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP
Lung LLCNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Belgium;Ireland;Germany
7EUCTR2009-014246-29-DE
(EUCTR)
08/04/201016/11/2009A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) Pulmonary Arterial Hypertension
MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Lung RxNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Czech Republic;Germany;Belgium;Ireland
8EUCTR2009-014246-29-CZ
(EUCTR)
18/02/201007/12/2009A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) Pulmonary Arterial Hypertension
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP
Lung Rx IncNULLNot RecruitingFemale: yes
Male: yes
36Germany;Czech Republic;Belgium;Ireland
9NCT00989963
(ClinicalTrials.gov)
February 1, 20105/10/2009Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)A 12-week, Double-blind, International, Multicenter, Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll36Phase 2United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic
10EUCTR2009-014246-29-IE
(EUCTR)
01/02/201006/11/2009A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) Pulmonary Arterial Hypertension
MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Lung RxNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Germany;Belgium;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2009-014453-32-IE
(EUCTR)
01/02/201009/11/2009An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patientsAn open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients 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
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP
Lung LLC IncNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Belgium;Ireland;Germany
12EUCTR2009-014453-32-BE
(EUCTR)
11/01/201009/11/2009An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patientsAn open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients 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]
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP
Lung LLCNULLNot RecruitingFemale: yes
Male: yes
36Phase 2United States;Czech Republic;Belgium;Ireland;Romania;Germany
13EUCTR2009-014246-29-BE
(EUCTR)
09/12/200909/11/2009A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) Pulmonary Arterial Hypertension
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP
Lung Rx IncNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Czech Republic;Belgium;Ireland;Germany
14NCT00990314
(ClinicalTrials.gov)
November 30, 20095/10/2009Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) PatientsPulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll31Phase 2United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic
15EUCTR2008-003290-41-IE
(EUCTR)
29/06/200911/12/2008A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patientsA Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP
LungRxNULLNot RecruitingFemale: yes
Male: yes
10Belgium;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2008-006833-29-IE
(EUCTR)
29/06/200911/12/2008An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients 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]
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP
Lung LLCNULLNot RecruitingFemale: yes
Male: yes
19Belgium;Ireland
17ChiCTR-TCC-12002776
2009-05-012012-10-23BEraproST combined therapy with Sildenafil for pulmonary arterial hypertensionBEraproST combined therapy with Sildenafil for pulmonary arterial hypertension Pulmonary arterial hypertensionGroup B :beraprost combined with sildenafil ;A:Sildenafil citrate ;Shanghai Pulmonary HospitalNULLCompleted1865BothGroup B :30;A:30;China
18NCT00792571
(ClinicalTrials.gov)
February 28, 200914/11/2008An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.Pulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll18Phase 2United States;Belgium;Ireland
19EUCTR2008-006833-29-BE
(EUCTR)
04/02/200916/12/2008An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients 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]
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP
Lung LLCNULLNot RecruitingFemale: yes
Male: yes
19Phase 2United States;Belgium;Ireland
20EUCTR2008-003290-41-BE
(EUCTR)
04/02/200909/12/2008A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patientsA Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP
Lung RxNULLNot RecruitingFemale: yes
Male: yes
20Belgium;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00781885
(ClinicalTrials.gov)
January 31, 200927/10/2008A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH PatientsA Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH PatientsPulmonary Arterial HypertensionDrug: Beraprost sodium modified releaseLung Biotechnology PBCNULLCompleted18 Years75 YearsAll19Phase 2United States;Belgium;Ireland
22JPRN-UMIN000001350
2008/09/0101/10/2008Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases Pulmonary arterial hypertension (PAH) associated with connective tissue diseaseBeraprost sodium
Beraprost sodium and Sildenafil citrate
Keio UniversityNULLComplete: follow-up complete18years-old80years-oldMale and Female70Not selectedJapan
23EUCTR2009-014453-32-DE
(EUCTR)
11/12/2009An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patientsAn open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients Pulmonary Arterial Hypertension
MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP
Lung RXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Czech Republic;Germany;Belgium;Ireland