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

  
54 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-002766-21-IE
(EUCTR)
23/04/201315/02/2013Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
2EUCTR2011-002766-21-CZ
(EUCTR)
03/08/201219/06/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
3EUCTR2011-002766-21-IT
(EUCTR)
25/07/201219/06/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Chile;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;China;Japan;Korea, Republic of
4EUCTR2011-002766-21-DE
(EUCTR)
02/07/201204/05/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
5EUCTR2011-002766-21-BE
(EUCTR)
26/06/201226/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
SCS Boehringer Ingelheim Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
6EUCTR2011-002766-21-ES
(EUCTR)
18/06/201226/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim España S.ANULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Russian Federation;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
7EUCTR2011-002766-21-GB
(EUCTR)
15/06/201221/05/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) - Idiopathic Pulmonary Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
8NCT01619085
(ClinicalTrials.gov)
June 6, 20126/6/2012Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary FibrosisAn Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: BIBF 1120Boehringer IngelheimNULLActive, not recruiting40 YearsN/AAll752Phase 3United States;Australia;Belgium;Canada;Chile;China;Czechia;Finland;France;Germany;Greece;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Czech Republic
9EUCTR2011-002766-21-FI
(EUCTR)
06/06/201216/05/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
10EUCTR2011-002766-21-GR
(EUCTR)
02/05/201211/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim HellasNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Russian Federation;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
11EUCTR2011-002766-21-PT
(EUCTR)
20/04/201220/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Unilfarma - União Internacional de Lab. Farmacêuticos, LdaNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
12NCT01417156
(ClinicalTrials.gov)
September 201115/8/2011Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary FibrosisPulmonary FibrosisDrug: Nintedanib;Drug: PirfenidoneoneBoehringer IngelheimNULLCompleted40 YearsN/AAll20Phase 2Japan
13EUCTR2010-024252-29-NL
(EUCTR)
16/06/201111/05/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Germany;Netherlands
14EUCTR2010-024252-29-ES
(EUCTR)
25/05/201103/11/2011-A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: BIBF1120
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: BIBF1120
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
485Phase 3United States;Portugal;Greece;Finland;Spain;Turkey;Russian Federation;Chile;India;France;Mexico;Canada;Germany;Netherlands;China;Japan;Korea, Republic of
15EUCTR2010-024251-87-BE
(EUCTR)
18/05/201117/03/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
485Phase 3United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;Australia;Germany;Japan;China
16EUCTR2010-024252-29-PT
(EUCTR)
13/05/201116/02/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
485China;Japan;Korea, Republic of;United States;Portugal;Greece;Finland;Spain;Russian Federation;India;France;Mexico;Canada;Germany;Netherlands
17EUCTR2010-024251-87-IE
(EUCTR)
11/05/201123/03/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
485Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom
18EUCTR2010-024251-87-IT
(EUCTR)
10/05/201119/09/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: BIBF 1120
Product Code: BIBF 1120
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
646Czech Republic;Belgium;Ireland;Germany;United Kingdom;Italy
19EUCTR2010-024252-29-GR
(EUCTR)
02/05/201104/04/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Netherlands;Germany
20NCT01335477
(ClinicalTrials.gov)
May 201113/4/2011Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients IIA 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)Pulmonary FibrosisDrug: placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll551Phase 3United States;Canada;Chile;China;Finland;France;Germany;Greece;India;Japan;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;Spain;Turkey
21EUCTR2010-024251-87-GB
(EUCTR)
28/04/201124/02/2011Safety and efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
485Phase 3Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom
22EUCTR2010-024251-87-CZ
(EUCTR)
26/04/201108/04/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim RCV GmBH & Co KGNULLNot RecruitingFemale: yes
Male: yes
485India;Czech Republic;Argentina;Brazil;Belgium;Australia;Germany;China;Japan;United States;Ireland;Israel;Italy;United Kingdom
23EUCTR2010-024251-87-DE
(EUCTR)
12/04/201109/02/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
485United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;China;Japan;Germany;Australia
24EUCTR2010-024252-29-DE
(EUCTR)
07/04/201109/02/2011Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patientsA 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10037383;Term: Pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
485Portugal;United States;Greece;Finland;Spain;Turkey;Russian Federation;Chile;India;France;Mexico;Canada;Netherlands;Germany;Japan;China;Korea, Republic of
25EUCTR2010-024252-29-FI
(EUCTR)
01/04/201104/02/2011A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
485Portugal;Greece;Finland;Spain;Netherlands;Germany
26NCT01335464
(ClinicalTrials.gov)
April 201113/4/2011Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis PatientsA 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)Pulmonary FibrosisDrug: placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll515Phase 3United States;Australia;Belgium;China;Czech Republic;France;Germany;India;Ireland;Israel;Italy;Japan;United Kingdom;Argentina;Brazil
27EUCTR2009-013788-21-BG
(EUCTR)
05/10/201018/08/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim RCV GmBH & Co KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
28EUCTR2009-013788-21-IE
(EUCTR)
05/08/201020/05/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim LtdNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
29EUCTR2009-013788-21-CZ
(EUCTR)
02/08/201028/07/2010study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary FibrosisA phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;Greece;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany
30EUCTR2009-013788-21-GR
(EUCTR)
14/07/201015/11/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Ellas AENULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
31NCT01170065
(ClinicalTrials.gov)
June 25, 20106/7/2010Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary FibrosisPulmonary FibrosisDrug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll198Phase 2Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Ireland;Italy;Mexico;Netherlands;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;El Salvador
32EUCTR2009-013788-21-HU
(EUCTR)
16/06/201005/07/2010A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary FibrosisA phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: Not applicable
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: Not applicable
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: Not applicable
Boehringer Ingelheim RCV GmBH & Co KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
33EUCTR2009-013788-21-GB
(EUCTR)
04/06/201011/10/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;Italy;United Kingdom
34EUCTR2009-013788-21-DE
(EUCTR)
27/05/201022/04/2010Roll over study from 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;Greece;Spain;Ireland;Russian Federation;Chile;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;China;Korea, Republic of
35EUCTR2009-013788-21-PT
(EUCTR)
10/05/201018/03/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Unilfarma, Lda.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;Portugal;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
36NCT01136174
(ClinicalTrials.gov)
May 201031/5/2010Safety and PK Study of BIBF 1120 in Japanese Patients With IPFA Double-blind, Randomised, Placebo-controlled (Within a Dose Group) Study to Evaluate Safety and Pharmacokinetics of Multiple Rising Doses of BIBF 1120 at 50 mg Bid (14 Days), 100 mg Bid (14 Days), and 150 mg Bid (28 Days) p.o., on Top of Standard Medical Care With Stratification According to Pirfenidone Use, in Japanese Patients With Idiopathic Pulmonary Fibrosis.Idiopathic Pulmonary FibrosisDrug: Placebo;Drug: BIBF 1120Boehringer IngelheimNULLCompleted40 YearsN/AAll50Phase 2Japan
37EUCTR2009-013788-21-ES
(EUCTR)
28/04/201023/02/2010Ensayo clínico de Fase II, abierto, y de extensión para evaluar la tolerabilidad a largo plazo, la seguridad y la eficacia de BIBF 1120 administrado por vía oral en pacientes con Fibrosis Pulmonar IdiopáticaA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisEnsayo clínico de Fase II, abierto, y de extensión para evaluar la tolerabilidad a largo plazo, la seguridad y la eficacia de BIBF 1120 administrado por vía oral en pacientes con Fibrosis Pulmonar IdiopáticaA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Fibrosis Pulmonar Idiopática
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim España S.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
38EUCTR2009-013788-21-BE
(EUCTR)
22/04/201008/03/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Germany;United Kingdom;Italy
39EUCTR2009-013788-21-FR
(EUCTR)
09/04/201008/03/2010A phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary FibrosisA phase II open label, roll over study of the long term tolerability,safety and efficacy of oral BIBF 1120 in patients with IdiopathicPulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
40EUCTR2009-013788-21-IT
(EUCTR)
07/04/201026/03/2010A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis - NDA phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis - ND Idiopathic Pulmonary Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10021240
Product Code: BIBF 1120
Product Code: BIBF 1120
Product Code: BIBF 1120
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy
41EUCTR2006-002875-42-BG
(EUCTR)
12/05/200809/05/2008A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;France;Bulgaria;Spain;Ireland;Italy;Greece
42EUCTR2006-002875-42-GR
(EUCTR)
22/01/200820/09/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
43EUCTR2006-002875-42-PT
(EUCTR)
11/01/200812/09/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
400Hungary;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
44EUCTR2006-002875-42-CZ
(EUCTR)
19/12/200710/07/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Greece;Spain;Ireland;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany;Netherlands
45EUCTR2006-002875-42-GB
(EUCTR)
20/11/200714/10/2010A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;Greece;Spain;Ireland;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
46EUCTR2006-002875-42-HU
(EUCTR)
26/09/200727/06/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim RCV Ges mbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
47EUCTR2006-002875-42-IE
(EUCTR)
11/09/200712/06/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
48EUCTR2006-002875-42-FR
(EUCTR)
23/08/200726/07/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim France SASNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Portugal;Greece;Spain;Ireland;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
49EUCTR2006-002875-42-ES
(EUCTR)
20/08/200719/06/2007Ensayo clínico randomizado, doble ciego, controlado con placebo de 12 meses de duración para evaluar el efecto de BIBF 1120 administrado por vía oral a dosis de 50 mg o.d., 50, 100 y 150 mg b.i.d. sobre la disminución anual de la Capacidad Vital Forzada (CVF) en pacientes con Fibrosis Pulmonar Idiopática, con una fase de extensión opcional hasta el final del ensayo.A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out.Ensayo clínico randomizado, doble ciego, controlado con placebo de 12 meses de duración para evaluar el efecto de BIBF 1120 administrado por vía oral a dosis de 50 mg o.d., 50, 100 y 150 mg b.i.d. sobre la disminución anual de la Capacidad Vital Forzada (CVF) en pacientes con Fibrosis Pulmonar Idiopática, con una fase de extensión opcional hasta el final del ensayo.A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. Fibrosis pulmonar idiopática
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Ireland;Spain;Italy;Greece
50EUCTR2006-002875-42-BE
(EUCTR)
14/08/200724/05/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
51NCT00514683
(ClinicalTrials.gov)
August 20079/8/2007Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary FibrosisA 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out.Pulmonary FibrosisDrug: low dose BIBF1120 once daily;Drug: low dose BIBF 1120 twice daily;Drug: intermediate dose BIBF 1120 twice daily;Drug: high dose BIBF 1120 twice daily;Drug: placeboBoehringer IngelheimNULLCompleted40 YearsN/AAll432Phase 2Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czech Republic;France;Germany;Greece;Hungary;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;South Africa;Spain;Taiwan;Turkey;United Kingdom;El Salvador
52EUCTR2006-002875-42-IT
(EUCTR)
17/07/200709/08/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out.A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. idiopathic pulmonary fibrosis (IPF)
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: NA
Product Code: BIBF 1120 ES
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;France;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Netherlands;Germany;United Kingdom;Italy
53EUCTR2006-002875-42-NL
(EUCTR)
16/07/200704/06/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
400Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece
54EUCTR2006-002875-42-DE
(EUCTR)
06/07/200708/05/2007A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPFA 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out. - Effect of orally administered BIBF 1120 on FVC decline in IPF Idiopathic pulmonary fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis
Product Name: BIBF 1120
Product Code: BIBF 1120
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
400Portugal;France;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Netherlands;Germany;United Kingdom;Italy