85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details
臨床試験数 : 598 / 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
| 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-UMIN000004749 | 2011/01/01 | 18/12/2010 | A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and idiopathic pulmonary fibrosis (IPF), respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension. | Patients with COPD or IPF (WHO functional class II, III or IV), without hypoxia (PaO2 at rest<90mmHg or after 6minutes walk), who provide their informed consent to participate in this study. | Treated subgroup In patients with COPD without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with Pulmonary hypertension with evidense of mPAP at rest=/>35mmHg : 20subjects Bosentan will be administered basically according to the approved dosage and administration, as specified below. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition. Treatment with bosentan in adults is usually initiated at a dose of 62.5 mg twice daily to be taken orally after breakfast and the evening meal for 4 weeks. From Week 5 of treatment, bosentan is administered at a dose of 125 mg twice daily to be taken orally after breakfast and evening meal. The dosage should be adjusted according to the patient's symptoms and tolerability, but should not exceed 250 mg per day. Duration of study drug administration: 24 months In addition, Interventions/Control 11 and 12 is described in Interventions/control 10. Treated subgroup In patients with COPD without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with boarderline pulmonary hypertension or pulmonary hypertension (mPAP at rest=/>25mmHg and/or mPAP on effort=/>30mmHg) with mPAP at rest<35mmHg: 20subjects Tracleer Tablets will be administered basically according to the approved dosage and administration, as specified below. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition. Treatment with bosentan in adults is usually initiated at a dose of 62.5 mg twice daily to be taken orally after breakfast and the evening meal for 4 weeks. From Week 5 of treatment, bosentan is administered at a dose of 125 mg twice daily to be taken orally after breakfast and even | Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School | NULL | Recruiting | 40years-old | Not applicable | Male and Female | 160 | Not applicable | Japan | |
| 2 | 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 | |||
| 3 | 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 | |||
| 4 | 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 | ||
| 5 | 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 | |||
| 6 | 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 | ||
| 7 | 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 | |||
| 8 | 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 | |||
| 9 | 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 | |||
| 10 | 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 | |||
| 11 | EUCTR2007-001741-18-IT (EUCTR) | 07/03/2008 | 23/03/2009 | 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 | Idipathic Pulmonary Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10001892;Term: Alveolitis fibrosing | Trade Name: TRACLEER INN or Proposed INN: Bosentan | Actelion Registration Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 12 | EUCTR2007-001645-17-GB (EUCTR) | 04/12/2007 | 10/10/2007 | Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung Disease | Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung Disease | Pulmonary hypertension in patients with interstitial lung disease. Specifically this trial looks at patients who have mild pulmonary hypertension, or are in an at-risk group to developing pulmonary hypertension, in the context of their interstitial lung disease. The interstitial lung diseases addressed include idiopathic pulmonary fibrosis and non-specific interstitial pneumonitis. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: Tracleer | Royal Brompton and Harefield NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | EUCTR2006-001183-24-IT (EUCTR) | 11/12/2006 | 05/01/2007 | 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 | Patients with Idiopathic pulmonary fibrosis Level: PTClassification code 10037383 | Trade 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 | ||
| 24 | EUCTR2006-001183-24-FR (EUCTR) | 28/11/2006 | 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 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer 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 |