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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
55 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-021825-11-BG
(EUCTR)
02/01/201320/11/2012A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a dayAn open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Phase 3Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
2EUCTR2011-004106-16-BG
(EUCTR)
10/08/201211/06/2012A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compoundA randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
105United States;Serbia;Portugal;Philippines;Taiwan;Ukraine;Guatemala;Russian Federation;Chile;Colombia;Vietnam;India;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
3EUCTR2011-004612-31-PT
(EUCTR)
06/07/201202/05/2012A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
105Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
4EUCTR2011-004106-16-PT
(EUCTR)
01/06/201228/02/2012A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compoundA randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
105Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
5EUCTR2010-021793-12-NL
(EUCTR)
09/11/201114/02/2011A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extensionA prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Germany;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT01389206
(ClinicalTrials.gov)
June 1, 20116/7/2011Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial HypertensionDrug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or UptraviActelionCanadian Heart Research CentreCompleted18 YearsN/AAll797United States;Puerto Rico
7EUCTR2010-021793-12-ES
(EUCTR)
28/04/201103/03/2011Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonarEstudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar Hipertensión arterial pulmonar (PAH) en niños.
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película
INN or Proposed INN: BOSENTAN MONOHIDRATO
Other descriptive name: BOSENTAN MONOHIDRATO
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Netherlands;Germany;Italy
8EUCTR2010-021825-11-NL
(EUCTR)
28/04/201103/11/2010A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a dayAn open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Germany;Netherlands;China
9EUCTR2010-021793-12-IT
(EUCTR)
10/04/201116/05/2011A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Study ExtensionA prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Study Extension Pulmonary Arterial Hypertension
MedDRA version: 13.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 13.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: TRACLEER
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Netherlands;Germany;Italy
10EUCTR2010-021793-12-DE
(EUCTR)
04/04/201101/02/2011A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a dayA prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;South Africa;Germany;Netherlands;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2010-021793-12-CZ
(EUCTR)
09/03/201104/02/2011A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a dayA prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China
12EUCTR2010-021793-12-HU
(EUCTR)
28/02/201102/02/2011A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a dayA prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64South Africa;Netherlands;Germany;China;United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia
13EUCTR2010-021344-17-IT
(EUCTR)
28/01/201107/02/2011A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - NDA non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND Pulmonary arterial hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911
Trade Name: GLIVEC
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: REVATIO
INN or Proposed INN: Sildenafil
Trade Name: TRACLEER
INN or Proposed INN: Bosentan
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
24Italy
14EUCTR2010-021825-11-IT
(EUCTR)
17/01/201108/02/2011An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE-3An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE-3 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064908
MedDRA version: 9.1;Classification code 10064909
MedDRA version: 9.1;Classification code 10064910
Trade Name: TRACLEER
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
15EUCTR2010-021825-11-ES
(EUCTR)
22/12/201012/11/2010Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 Hpertensión arterial pulmonar (PAH) en niños
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película
INN or Proposed INN: BOSENTAN MONOHIDRATO
Other descriptive name: BOSENTAN MONOHIDRATO
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2010-021825-11-HU
(EUCTR)
08/12/201004/11/2010An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
17EUCTR2010-021825-11-CZ
(EUCTR)
03/12/201003/12/2010A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a dayAn open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
18EUCTR2010-021825-11-DE
(EUCTR)
26/11/201008/11/2010A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a dayAn open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
19EUCTR2008-004533-21-NL
(EUCTR)
25/06/201014/11/2008The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patientsThe role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patients To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: Tracleer
Product Code: 66215-101
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ICINNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Netherlands
20EUCTR2005-005068-97-BE
(EUCTR)
29/10/200910/06/2009Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Spain;Belgium;Denmark;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2005-005068-97-CZ
(EUCTR)
16/06/200911/06/2009Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
22EUCTR2005-005068-97-GR
(EUCTR)
23/09/200820/02/2009Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 4Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden
23EUCTR2007-001643-21-GB
(EUCTR)
26/06/200810/10/2007 Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension Pulmonary hypertension in patients with interstitial lung disease.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Royal Brompton and Harefield NHS TrustNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
24EUCTR2005-005068-97-PT
(EUCTR)
06/06/200811/03/2008Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term:
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
25EUCTR2005-005068-97-ES
(EUCTR)
11/05/200803/03/2008Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 Hipertensión Arterial PulmonarPatients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term:
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 4Portugal;Czech Republic;United Kingdom;Germany;Denmark;Spain;Greece;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2005-005068-97-SK
(EUCTR)
06/03/200806/07/2010A clinical trial to investigate the safety and effectiveness of the combination of bosentan and sildenafil to treat patients with symptomatic pulmonary arterial hypertension in comparison to treatment with sildenafil on its ownEffects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Germany;Sweden
27EUCTR2007-001645-17-GB
(EUCTR)
04/12/200710/10/2007Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung DiseasePrevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung Disease Pulmonary hypertension in patients with interstitial lung disease. Specifically this trial looks at patients who have mild pulmonary hypertension, or are in an at-risk group to developing pulmonary hypertension, in the context of their interstitial lung disease. The interstitial lung diseases addressed include idiopathic pulmonary fibrosis and non-specific interstitial pneumonitis.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: Tracleer
Royal Brompton and Harefield NHS TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
28EUCTR2005-005068-97-GB
(EUCTR)
30/10/200714/06/2007Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Phase 4Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden
29EUCTR2005-005068-97-DK
(EUCTR)
12/09/200711/05/2007Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
30EUCTR2005-005068-97-SE
(EUCTR)
18/06/200702/04/2007Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2004-000745-37-GB
(EUCTR)
10/10/200623/02/2005Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - ExtensionUncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosisTrade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Spain;Italy;United Kingdom
32EUCTR2006-000021-57-DK
(EUCTR)
10/03/200624/02/2006Bosentan and Sildenfil for patients with Eisenmenger syndromeBosentan and Sildenfil for patients with Eisenmenger syndrome Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).Trade Name: Tracleer
Product Name: Tracleer
Other descriptive name: Bosentan monohydrat
Trade Name: VIAGRA
Product Name: Viagra
Other descriptive name: sildenafil
RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
20Denmark
33EUCTR2004-004391-36-CZ
(EUCTR)
20/01/200605/01/2006A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertensionA multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: no
Male: yes
23Hungary;Czech Republic
34EUCTR2004-005157-63-IT
(EUCTR)
15/06/200515/02/2006An open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAHAn open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAH Treatment of pulmonary arterial hypertension in children.
MedDRA version: 6.1;Level: PT;Classification code 10037405
Trade Name: TRACLEER 62,5MG 56CPR RIV.
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
35United Kingdom;Italy
35EUCTR2004-004391-36-HU
(EUCTR)
23/05/200523/02/2005A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertensionA multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: no
Male: yes
23Hungary;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2004-000745-37-IT
(EUCTR)
15/03/200521/06/2005Uncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension)Uncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension) No modification of the label due to the fact that is an open label extension of a phase IV trial.
MedDRA version: 6.1;Level: PT;Classification code 10037406
Trade Name: TRACLEER*125MG 56CPR RIV.
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
United Kingdom;Spain;Italy
37EUCTR2004-000478-30-ES
(EUCTR)
10/02/200503/11/2004Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients.Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
38EUCTR2004-000478-30-BE
(EUCTR)
14/12/200424/08/2005Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;Spain;Belgium;Denmark;Austria;Italy;United Kingdom;Sweden
39EUCTR2004-000478-30-AT
(EUCTR)
08/12/200403/11/2004Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;Spain;Denmark;Austria;Italy;United Kingdom;Sweden
40EUCTR2004-000478-30-CZ
(EUCTR)
26/11/200426/11/2004Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
170United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2004-000478-30-SE
(EUCTR)
28/10/200420/07/2004Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
170United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
42EUCTR2004-000745-37-ES
(EUCTR)
11/10/200407/10/2004Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - ExtensionUncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosisTrade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50United Kingdom;Spain;Italy
43EUCTR2004-000478-30-DK
(EUCTR)
10/09/200410/01/2007Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
170United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
44EUCTR2004-000478-30-IT
(EUCTR)
09/09/200411/07/2007A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYA randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Treatment of pulmonary arterial hypertension (PAH) in patients with grade II modified NYHA
MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: TRACLEER*56CPR RIV 125MG
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;Spain;Denmark;United Kingdom;Italy;Sweden
45NCT00367770
(ClinicalTrials.gov)
January 200421/8/2006BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyA Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyPulmonary Arterial HypertensionDrug: Tracleer®ActelionNULLCompleted12 YearsN/AAll37Phase 4United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00317486
(ClinicalTrials.gov)
September 200321/4/2006Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyA Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Tracleer (Bosentan) on Oxygen Saturation and Cardiac Hemodynamics in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyPulmonary Arterial Hypertension Related to Eisenmenger PhysiologyDrug: bosentanActelionNULLCompleted12 YearsN/ABoth54Phase 4United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
47NCT00082186
(ClinicalTrials.gov)
July 200330/4/2004The Effect of Tracleer® on Male FertilityTRACLEER® (Bosentan) Pulmonary Arterial Hypertension A Multicenter, Open-label, Single-arm Safety Study to Investigate the Effects of Chronic TRACLEER® Treatment on Testicular Function in Male Patients With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: bosentanActelionNULLCompleted18 Years65 YearsMale22Phase 4United States;Australia;Brazil;Czech Republic;Hungary
48EUCTR2011-004106-16-FR
(EUCTR)
17/02/2012A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compoundA randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNAFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China
49EUCTR2010-021793-12-FR
(EUCTR)
04/02/2011A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extensionA prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
64Phase 3France;Czech Republic;Hungary;Poland;Spain;Netherlands;Germany;Italy
50EUCTR2010-021793-12-PL
(EUCTR)
25/07/2011A 1 year follow-up research project for children with pulmonary arterial hypertension (PAH) that participated in the FUTURE 3 core study. This is to find out how well bosentan is tolerated and safe when taken either two or three times a dayA prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Phase 3Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2005-005068-97-DE
(EUCTR)
13/02/2006Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Viagra
INN or Proposed INN: sildenafil (as citrate)
Trade Name: Viagra
INN or Proposed INN: sildenafil (as citrate)
Trade Name: Viagra
INN or Proposed INN: sildenafil
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
52EUCTR2011-004106-16-NL
(EUCTR)
10/02/2012A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compoundA randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNAFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Guatemala;Ukraine;Russian Federation;Chile;Colombia;India;Vietnam;France;Mexico;Argentina;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
53EUCTR2011-004612-31-NL
(EUCTR)
07/05/2012A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNAFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China
54EUCTR2010-021825-11-FR
(EUCTR)
13/12/2010An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
64Phase 3France;Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
55EUCTR2011-004612-31-FR
(EUCTR)
27/08/2012A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 15.0;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 15.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNAFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China