BPS-MR ( 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15

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
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
Inclusion_
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PhaseCountries
1EUCTR2009-014453-32-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
2EUCTR2009-014246-29-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 RxNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Czech Republic;Belgium;Ireland;Germany
3EUCTR2009-014246-29-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
4EUCTR2009-014453-32-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
5EUCTR2009-014246-29-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
6NCT00989963
(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
7EUCTR2009-014453-32-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
8EUCTR2009-014246-29-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
9NCT00990314
(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
10EUCTR2008-006833-29-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
11EUCTR2008-003290-41-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
12NCT00792571
(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
13EUCTR2008-006833-29-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
14EUCTR2008-003290-41-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
15EUCTR2009-014453-32-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 RXNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Czech Republic;Belgium;Ireland;Germany