85. 特発性間質性肺炎 [臨床試験数:514,薬物数:377(DrugBank:108),標的遺伝子数:97,標的パスウェイ数:204

Searched query = "Idiopathic interstitial pneumonia", "IIPs", "Idiopathic pulmonary fibrosis", "IPF", "Usual interstitial pneumonia", "UIP", "Non-specific interstitial pneumonia", "NSIP", "Acute interstitial pneumonia", "AIP", "Diffuse alveolar damage", "DAD", "COP", "Organizing pneumonia", "OP", "Desquamative interstitial pneumonia", "DIP", "Respiratory bronchiolitis - associated interstitial lung disease", "RB-ILD", "Lymphocytic interstitial pneumonia", "LIP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
27 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000004749
2011/01/0118/12/2010A 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 SchoolNULLRecruiting40years-oldNot applicableMale and Female160Not applicableJapan
2EUCTR2007-001741-18-AT
(EUCTR)
02/04/200907/04/2008Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OLOpen-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 LtdNULLNot RecruitingFemale: yes
Male: yes
390Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
3EUCTR2007-001741-18-NL
(EUCTR)
17/09/200830/05/2008Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OLOpen-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 LtdNULLNot RecruitingFemale: yes
Male: yes
390Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
4EUCTR2007-001741-18-IE
(EUCTR)
17/07/200812/03/2008Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OLOpen-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 LtdNULLNot RecruitingFemale: yes
Male: yes
390Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
5EUCTR2007-001741-18-FR
(EUCTR)
24/06/200804/02/2008Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OLOpen-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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2007-001741-18-CZ
(EUCTR)
16/06/200818/04/2008Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OLOpen-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 LtdNULLNot RecruitingFemale: yes
Male: yes
390Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
7EUCTR2007-001741-18-DE
(EUCTR)
23/05/200803/11/2008Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OLOpen-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 LtdNULLNot RecruitingFemale: yes
Male: yes
390France;Czech Republic;Belgium;Spain;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom
8EUCTR2007-001741-18-ES
(EUCTR)
21/04/200812/02/2008Estudio de extensión abierta en pacientes con Fibrosis Pulmonar Idiopática que hayan completado el protocolo AC-052-321 / BUILD 3 - BUILD-3-OLEstudio 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 LtdNULLNot RecruitingFemale: yes
Male: yes
390Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
9NCT00631475
(ClinicalTrials.gov)
April 200812/2/2008Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443)Idiopathic Pulmonary FibrosisDrug: BosentanActelionNULLCompleted18 YearsN/AAll128Phase 3United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Ireland;Israel;Italy;Japan;Korea, Republic of;Spain;Switzerland;United Kingdom;Austria;Croatia;Former Serbia and Montenegro;Netherlands;Serbia
10NCT00637065
(ClinicalTrials.gov)
April 200810/3/2008Bosentan in Pulmonary Hypertension in Interstitial Lung Disease Treatment StudyUse of the Endothelin-1 Antagonist Bosentan in Patients With Established Pulmonary Hypertension and Fibrotic Lung Disease. - A Randomised, Placebo-Controlled, Double-Blinded Study.Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Nonspecific Interstitial PneumoniaDrug: Bosentan;Drug: PlaceboRoyal Brompton & Harefield NHS Foundation TrustActelionNot yet recruiting18 Years80 YearsBoth48Phase 4United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2007-001741-18-BE
(EUCTR)
20/03/200814/03/2008Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OLOpen-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 LtdNULLNot RecruitingFemale: yes
Male: yes
390Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
12EUCTR2007-001741-18-IT
(EUCTR)
07/03/200823/03/2009Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321/BUILD 3 - Build-3 OLOpen-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 LtdNULLNot RecruitingFemale: yes
Male: yes
390Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
13NCT00625469
(ClinicalTrials.gov)
October 200719/2/2008Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With BosentanTreatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary FibrosisDrug: bosentanRajan SaggarActelionWithdrawnN/AN/AAll0Phase 4United States
14EUCTR2006-001183-24-IE
(EUCTR)
30/04/200716/11/2006Effects 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-3Effects 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 LTDNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
15EUCTR2006-001183-24-GB
(EUCTR)
09/03/200723/11/2006Effects 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-3Effects 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
ACTELION PHARMACEUTICALS LTDNULLNot 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): noFrance;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2006-001183-24-NL
(EUCTR)
06/03/200710/11/2006Effects 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-3Effects 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 LTDNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
17EUCTR2006-001183-24-SK
(EUCTR)
26/02/200719/01/2007Effects 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-3Effects 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 LTDNULLNot RecruitingFemale: yes
Male: yes
390Phase 3France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom
18EUCTR2006-001183-24-DE
(EUCTR)
22/02/200701/12/2006Effects 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-3Effects 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 LTDNULLNot RecruitingFemale: yes
Male: yes
600Phase 3France;Czech Republic;Spain;Belgium;Ireland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom
19EUCTR2006-001183-24-ES
(EUCTR)
14/02/200707/04/2010Efectos 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-3Efectos 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 LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
20EUCTR2006-001183-24-CZ
(EUCTR)
07/02/200721/12/2006Effects 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-3Effects 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 LTDNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00391443
(ClinicalTrials.gov)
February 200720/10/2006BUILD 3: Bosentan Use in Interstitial Lung DiseaseEffects 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.Idiopathic Pulmonary FibrosisDrug: Bosentan;Drug: PlaceboActelionNULLCompleted18 YearsN/AAll616Phase 3United States;Australia;Austria;Belgium;Canada;Croatia;Czech Republic;France;Germany;Ireland;Israel;Italy;Japan;Korea, Republic of;Netherlands;Serbia;Spain;Switzerland;United Kingdom;Denmark;Former Serbia and Montenegro;Slovakia
22EUCTR2006-001183-24-DK
(EUCTR)
24/01/200712/12/2006Effects 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-3Effects 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 LTDNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;France;Spain;Ireland;Italy;Austria
23EUCTR2006-001183-24-AT
(EUCTR)
10/01/200711/12/2006Effects 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-3Effects 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 LTDNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
24EUCTR2006-001183-24-BE
(EUCTR)
12/12/200614/11/2006Effects 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-3Effects 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 LTDNULLNot RecruitingFemale: yes
Male: yes
460Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
25EUCTR2006-001183-24-IT
(EUCTR)
11/12/200605/01/2007Effects 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 3Effects 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 LTDNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT00071461
(ClinicalTrials.gov)
August 200323/10/2003Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary FibrosisA Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label ExtensionIdiopathic Pulmonary FibrosisDrug: bosentan;Drug: PlaceboActelionNULLCompleted18 YearsN/ABoth158Phase 2/Phase 3United States;Canada;France;Germany;Israel;Italy;Switzerland;United Kingdom
27EUCTR2006-001183-24-FR
(EUCTR)
28/11/2006Effects 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-3Effects 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 LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria