Bosentan monohydrat    (DrugBank: Bosentan)

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38

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.
38 / 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
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
6EUCTR2010-021825-11-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
7EUCTR2010-021793-12-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
8EUCTR2010-021793-12-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
9EUCTR2010-021793-12-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
10EUCTR2010-021825-11-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2010-021825-11-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
12EUCTR2010-021825-11-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
13EUCTR2005-005068-97-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
14EUCTR2005-005068-97-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
15EUCTR2005-005068-97-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2005-005068-97-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
17EUCTR2005-005068-97-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
18EUCTR2005-005068-97-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
19EUCTR2004-000745-37-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
20EUCTR2006-000021-57-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2004-004391-36-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
22EUCTR2004-004391-36-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
23EUCTR2004-000478-30-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
24EUCTR2004-000478-30-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
25EUCTR2004-000478-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2004-000478-30-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
27EUCTR2004-000478-30-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
28EUCTR2004-000745-37-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
29EUCTR2004-000478-30-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
30EUCTR2011-004106-16-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2010-021793-12-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
32EUCTR2010-021793-12-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
33EUCTR2005-005068-97-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
34EUCTR2011-004106-16-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
35EUCTR2005-001967-70-DE
(EUCTR)
30/08/2005An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2 Idiopathic or familial pulmonary arterial hypertensionProduct Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
30United Kingdom;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2011-004612-31-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
37EUCTR2010-021825-11-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
38EUCTR2011-004612-31-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