Ro 47-0203 ( DrugBank: - )
4 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 51 | 全身性強皮症 | 1 |
| 85 | 特発性間質性肺炎 | 19 |
| 86 | 肺動脈性肺高血圧症 | 16 |
| 88 | 慢性血栓塞栓性肺高血圧症 | 9 |
51. 全身性強皮症
臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
| 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 | EUCTR2004-000632-82-GB (EUCTR) | 16/09/2004 | 11/02/2005 | Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension | Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension | SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascular damage and excessive accumulation of fibrosis in the skin and internal organs. As vascular damage progresses the microvascular bed in the skin and other sites is impaired, producing a state of chronic ischemia. SSc is commonly divided into the diffuse and limited form of the disease | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Italy;United Kingdom |
85. 特発性間質性肺炎
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
| 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 | EUCTR2007-001741-18-AT (EUCTR) | 02/04/2009 | 07/04/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 2 | EUCTR2007-001741-18-NL (EUCTR) | 17/09/2008 | 30/05/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 3 | EUCTR2007-001741-18-GB (EUCTR) | 25/07/2008 | 11/04/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 4 | EUCTR2007-001741-18-IE (EUCTR) | 17/07/2008 | 12/03/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 5 | EUCTR2007-001741-18-FR (EUCTR) | 24/06/2008 | 04/02/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | France;Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 6 | EUCTR2007-001741-18-CZ (EUCTR) | 16/06/2008 | 18/04/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 7 | EUCTR2007-001741-18-DE (EUCTR) | 23/05/2008 | 03/11/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | France;Czech Republic;Belgium;Spain;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | |||
| 8 | EUCTR2007-001741-18-ES (EUCTR) | 21/04/2008 | 12/02/2008 | Estudio de extensión abierta en pacientes con Fibrosis Pulmonar Idiopática que hayan completado el protocolo AC-052-321 / BUILD 3 - BUILD-3-OL | Estudio de extensión abierta en pacientes con Fibrosis Pulmonar Idiopática que hayan completado el protocolo AC-052-321 / BUILD 3 - BUILD-3-OL | Fibrosis Pulmonar Idiopática (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 9 | EUCTR2007-001741-18-BE (EUCTR) | 20/03/2008 | 14/03/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 10 | EUCTR2006-001183-24-IE (EUCTR) | 30/04/2007 | 16/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 11 | EUCTR2006-001183-24-GB (EUCTR) | 09/03/2007 | 23/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 12 | EUCTR2006-001183-24-NL (EUCTR) | 06/03/2007 | 10/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 13 | EUCTR2006-001183-24-SK (EUCTR) | 26/02/2007 | 19/01/2007 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 14 | EUCTR2006-001183-24-DE (EUCTR) | 22/02/2007 | 01/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Spain;Belgium;Ireland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 15 | EUCTR2006-001183-24-ES (EUCTR) | 14/02/2007 | 07/04/2010 | Efectos de Bosentan sobre la morbilidad y mortalidad en pacientes con Fibrosis Pulmonar Idiopática- Estudio fase III, multicéntrico, randomizado, de grupos paralelos, doble ciego, controlado con placebo, secuencial por grupos, condicionado por acontecimientos.English:Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Efectos de Bosentan sobre la morbilidad y mortalidad en pacientes con Fibrosis Pulmonar Idiopática- Estudio fase III, multicéntrico, randomizado, de grupos paralelos, doble ciego, controlado con placebo, secuencial por grupos, condicionado por acontecimientos.English:Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Spanish:Fibrosis Pulmonar IdiopáticaEnglish:Idiopathic Pulmonary Fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Slovakia;Belgium;Spain;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 16 | EUCTR2006-001183-24-CZ (EUCTR) | 07/02/2007 | 21/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 17 | EUCTR2006-001183-24-DK (EUCTR) | 24/01/2007 | 12/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;France;Spain;Ireland;Italy;Austria | ||
| 18 | EUCTR2006-001183-24-AT (EUCTR) | 10/01/2007 | 11/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 19 | EUCTR2006-001183-24-BE (EUCTR) | 12/12/2006 | 14/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria |
86. 肺動脈性肺高血圧症
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
| 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 | JPRN-JapicCTI-132155 | 01/8/2013 | 11/06/2013 | Bosentan extension study for PAH pediatric patients | Open-label, long-term, efficacy, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of Japanese children with pulmonary arterial hypertension who completed the previous study. | Pulmonary arterial hypertension (PAH) | Intervention name : Ro 47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d. | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 5 | Phase 3 | NULL | ||
| 2 | EUCTR2004-000745-37-GB (EUCTR) | 10/10/2006 | 23/02/2005 | Uncontrolled 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 | Uncontrolled 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 prognosis | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Spain;Italy;United Kingdom | |||
| 3 | EUCTR2004-004391-36-CZ (EUCTR) | 20/01/2006 | 05/01/2006 | 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 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 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. | NULL | Not Recruiting | Female: no Male: yes | 23 | Hungary;Czech Republic | |||
| 4 | EUCTR2005-001967-70-IT (EUCTR) | 20/10/2005 | 19/01/2007 | An 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 | An 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 | Treatment of pulmonary arterial hypertension in children MedDRA version: 14.1;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: Bosentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 35 | Germany;United Kingdom;Italy | |||
| 5 | EUCTR2005-001967-70-GB (EUCTR) | 13/10/2005 | 25/08/2005 | An 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 | An 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 hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Germany;Italy;United Kingdom | ||
| 6 | EUCTR2004-005157-63-GB (EUCTR) | 15/06/2005 | 19/04/2005 | An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1 | An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1 | Idiopathic or familial PAH | Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 33 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;United Kingdom | ||
| 7 | EUCTR2004-004391-36-HU (EUCTR) | 23/05/2005 | 23/02/2005 | 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 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 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. | NULL | Not Recruiting | Female: no Male: yes | 23 | Hungary;Czech Republic | |||
| 8 | EUCTR2004-000478-30-ES (EUCTR) | 10/02/2005 | 03/11/2004 | Endothelin 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 | Endothelin 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. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Czech Republic;Belgium;Spain;Denmark;Austria;Italy;United Kingdom;Sweden | ||
| 9 | EUCTR2004-000478-30-BE (EUCTR) | 14/12/2004 | 24/08/2005 | Endothelin 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 | Endothelin 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. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Spain;Belgium;Denmark;Austria;Italy;United Kingdom;Sweden | |||
| 10 | EUCTR2004-000478-30-AT (EUCTR) | 08/12/2004 | 03/11/2004 | Endothelin 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 | Endothelin 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. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Spain;Denmark;Austria;Italy;United Kingdom;Sweden | |||
| 11 | EUCTR2004-000478-30-CZ (EUCTR) | 26/11/2004 | 26/11/2004 | Endothelin 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 | Endothelin 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. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden | |||
| 12 | EUCTR2004-000478-30-SE (EUCTR) | 28/10/2004 | 20/07/2004 | Endothelin 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 | Endothelin 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. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden | |||
| 13 | EUCTR2004-000745-37-ES (EUCTR) | 11/10/2004 | 07/10/2004 | Uncontrolled 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 | Uncontrolled 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 prognosis | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 4 | Spain;Italy;United Kingdom | ||
| 14 | EUCTR2004-000478-30-DK (EUCTR) | 10/09/2004 | 10/01/2007 | Endothelin 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 | Endothelin 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. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden | |||
| 15 | EUCTR2004-000478-30-GB (EUCTR) | 15/07/2004 | 21/06/2005 | Endothelin 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 | Endothelin 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. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Belgium;Spain;Denmark;Austria;Italy;United Kingdom;Sweden | ||
| 16 | EUCTR2005-001967-70-DE (EUCTR) | 30/08/2005 | An 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 | An 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 hypertension | Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 30 | United Kingdom;Germany;Italy |
88. 慢性血栓塞栓性肺高血圧症
臨床試験数 : 157 / 薬物数 : 107 - (DrugBank : 22) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 54
| 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 | EUCTR2005-002900-40-GB (EUCTR) | 28/04/2006 | 27/02/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Spain;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2005-002900-40-CZ (EUCTR) | 13/03/2006 | 13/03/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Czech Republic;Spain;Italy | |||
| 3 | EUCTR2005-002900-40-DE (EUCTR) | 03/03/2006 | 23/01/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 8.1;Level: LLT;Classification code 10037436;Term: Pulmonary thromboembolism | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: TRACLEER Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: TRACLEER | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;Spain;Germany;Italy;United Kingdom | |||
| 4 | EUCTR2005-002900-40-BE (EUCTR) | 18/01/2006 | 09/01/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;Spain;Belgium;Austria;Germany;Italy;United Kingdom | |||
| 5 | EUCTR2005-001965-33-AT (EUCTR) | 15/12/2005 | 11/10/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Spain;Austria;Germany;Italy;United Kingdom | |||
| 6 | EUCTR2005-001965-33-CZ (EUCTR) | 16/11/2005 | 12/10/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 3 | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2005-001965-33-GB (EUCTR) | 04/11/2005 | 31/08/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2005-001965-33-DE (EUCTR) | 01/11/2005 | 29/08/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 8.1;Level: LLT;Classification code 10037436;Term: Pulmonary thromboembolism | 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. | NULL | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Spain;Italy | |||
| 9 | EUCTR2005-002900-40-AT (EUCTR) | 15/08/2005 | 07/11/2005 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom |