86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details
臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
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| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2010-021825-11-BG (EUCTR) | 02/01/2013 | 20/11/2012 | A 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 day A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hyper ... | An 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 An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety an ... | 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] Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTANMONOHYDRATE Other descriptive ... | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 3 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czec ... | ||
| 2 | EUCTR2011-004106-16-BG (EUCTR) | 10/08/2012 | 11/06/2012 | A 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 compound A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in ... | A 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 A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to a ... | 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] Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSEN ... | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | United 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 United States;Serbia;Portugal;Philippines;Taiwan;Ukraine;Guatemala;Russian Federation;Chile;Colombia ... | ||
| 3 | EUCTR2011-004612-31-PT (EUCTR) | 06/07/2012 | 02/05/2012 | A 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 12-month research project for children who have gone through the FUTURE 5 research project and who ... | 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 A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess sa ... | 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] Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSEN ... | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Portugal;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 Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia ... | |||
| 4 | EUCTR2011-004106-16-PT (EUCTR) | 01/06/2012 | 28/02/2012 | A 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 compound A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in ... | A 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 A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to a ... | 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] Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSEN ... | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Portugal;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 Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia ... | |||
| 5 | EUCTR2010-021793-12-NL (EUCTR) | 09/11/2011 | 14/02/2011 | A 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 A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and e ... | A 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 A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and e ... | 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) Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTANMONOHYDRATE Other descriptive ... | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Germany;Netherlands;Italy | |||
| 6 | EUCTR2010-021825-11-NL (EUCTR) | 28/04/2011 | 03/11/2010 | A 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 day A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hyper ... | An 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 An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety an ... | 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] Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTANMONOHYDRATE Other descriptive ... | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Germany;Netherlands;China Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czec ... | |||
| 7 | EUCTR2010-021793-12-DE (EUCTR) | 04/04/2011 | 01/02/2011 | A 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 day A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that part ... | A 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 A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and ... | 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] Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTANMONOHYDRATE Other descriptive ... | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;South Africa;Germany;Netherlands;China United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czec ... | |||
| 8 | EUCTR2010-021793-12-CZ (EUCTR) | 09/03/2011 | 04/02/2011 | A 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 day A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that part ... | A 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 A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and ... | 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] Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTANMONOHYDRATE Other descriptive ... | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republ ... | |||
| 9 | EUCTR2010-021793-12-HU (EUCTR) | 28/02/2011 | 02/02/2011 | A 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 day A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that part ... | A 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 A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and ... | 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] Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTANMONOHYDRATE Other descriptive ... | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | South Africa;Netherlands;Germany;China;United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia South Africa;Netherlands;Germany;China;United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Fed ... | |||
| 10 | EUCTR2010-021825-11-HU (EUCTR) | 08/12/2010 | 04/11/2010 | An 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 An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety an ... | An 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 An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety an ... | 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) Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTANMONOHYDRATE Other descriptive ... | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy |