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.
| 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 | EUCTR2011-002766-21-IE (EUCTR) | 23/04/2013 | 15/02/2013 | Long 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] | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United 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 | |||
| 2 | EUCTR2011-002766-21-CZ (EUCTR) | 03/08/2012 | 19/06/2012 | Long 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 KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United 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 | ||
| 3 | EUCTR2011-002766-21-IT (EUCTR) | 25/07/2012 | 19/06/2012 | Long 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. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;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 | ||
| 4 | EUCTR2011-002766-21-DE (EUCTR) | 02/07/2012 | 04/05/2012 | Long 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United 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 | ||
| 5 | EUCTR2011-002766-21-BE (EUCTR) | 26/06/2012 | 26/04/2012 | Long 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.V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | United 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 | |||
| 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 |
| 6 | EUCTR2011-002766-21-ES (EUCTR) | 18/06/2012 | 26/04/2012 | Long 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.A | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United 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 | ||
| 7 | EUCTR2011-002766-21-GB (EUCTR) | 15/06/2012 | 21/05/2012 | Long 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | United 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 | ||
| 8 | EUCTR2011-002766-21-FI (EUCTR) | 06/06/2012 | 16/05/2012 | Long 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 Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United 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 | ||
| 9 | NCT01619085 (ClinicalTrials.gov) | June 6, 2012 | 6/6/2012 | Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis | An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: BIBF 1120 | Boehringer Ingelheim | NULL | Active, not recruiting | 40 Years | N/A | All | 752 | Phase 3 | United 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 |
| 10 | EUCTR2011-002766-21-GR (EUCTR) | 02/05/2012 | 11/04/2012 | Long 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 Hellas | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United 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 | ||
| 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 |
| 11 | EUCTR2011-002766-21-PT (EUCTR) | 20/04/2012 | 20/04/2012 | Long 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, Lda | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United 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 | ||
| 12 | NCT01417156 (ClinicalTrials.gov) | September 2011 | 15/8/2011 | Safety 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 Fibrosis | Pulmonary Fibrosis | Drug: Nintedanib;Drug: Pirfenidoneone | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 20 | Phase 2 | Japan |
| 13 | EUCTR2010-024252-29-NL (EUCTR) | 16/06/2011 | 11/05/2011 | 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) | 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 Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 485 | Portugal;Greece;Finland;Spain;Germany;Netherlands | |||
| 14 | EUCTR2010-024252-29-ES (EUCTR) | 25/05/2011 | 03/11/2011 | - | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Portugal;Germany;Turkey;Netherlands;Chile;France;Finland;India;Russian Federation;Canada;Mexico;China;Korea, Republic of;Spain;Japan;United States;Greece | |||
| 15 | EUCTR2010-024251-87-BE (EUCTR) | 18/05/2011 | 17/03/2011 | 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) | 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.V | NULL | Not Recruiting | Female: yes Male: yes | 485 | Phase 3 | United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;Australia;Germany;Japan;China | ||
| 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 |
| 16 | EUCTR2010-024252-29-PT (EUCTR) | 13/05/2011 | 16/02/2011 | 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) | 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 France | NULL | Not Recruiting | Female: yes Male: yes | 485 | China;Japan;Korea, Republic of;United States;Portugal;Greece;Finland;Spain;Russian Federation;India;France;Mexico;Canada;Germany;Netherlands | |||
| 17 | EUCTR2010-024251-87-IE (EUCTR) | 11/05/2011 | 23/03/2011 | 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) | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 485 | Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom | |||
| 18 | EUCTR2010-024251-87-IT (EUCTR) | 10/05/2011 | 19/09/2011 | 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) | 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. | NULL | Not Recruiting | Female: yes Male: yes | 646 | Czech Republic;Belgium;Ireland;Germany;United Kingdom;Italy | |||
| 19 | EUCTR2010-024252-29-GR (EUCTR) | 02/05/2011 | 04/04/2011 | 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) | 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 Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 485 | Portugal;Greece;Finland;Spain;Netherlands;Germany | |||
| 20 | NCT01335477 (ClinicalTrials.gov) | May 2011 | 13/4/2011 | Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II | 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) | Pulmonary Fibrosis | Drug: placebo;Drug: BIBF 1120 | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 551 | Phase 3 | United States;Canada;Chile;China;Finland;France;Germany;Greece;India;Japan;Korea, Republic of;Mexico;Netherlands;Portugal;Russian Federation;Spain;Turkey |
| 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 |
| 21 | EUCTR2010-024251-87-GB (EUCTR) | 28/04/2011 | 24/02/2011 | Safety and efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 485 | Phase 3 | Czech Republic;Belgium;Ireland;Germany;Italy;United Kingdom | ||
| 22 | EUCTR2010-024251-87-CZ (EUCTR) | 26/04/2011 | 08/04/2011 | Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients | 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;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 KG | NULL | Not Recruiting | Female: yes Male: yes | 485 | India;Czech Republic;Argentina;Brazil;Belgium;Australia;Germany;China;Japan;United States;Ireland;Israel;Italy;United Kingdom | |||
| 23 | EUCTR2010-024251-87-DE (EUCTR) | 12/04/2011 | 09/02/2011 | Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients | 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;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. KG | NULL | Not Recruiting | Female: yes Male: yes | 485 | United States;Ireland;Israel;Italy;United Kingdom;India;France;Czech Republic;Argentina;Belgium;Brazil;Australia;Germany;Japan;China | |||
| 24 | EUCTR2010-024252-29-DE (EUCTR) | 07/04/2011 | 09/02/2011 | Safety and Efficacy of BIBF 1120 at high dose in Idiopathic Pulmonary Fibrosis patients | 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: 14.1;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. KG | NULL | Not Recruiting | Female: yes Male: yes | 485 | Portugal;United States;Greece;Finland;Spain;Turkey;Russian Federation;Chile;India;France;Mexico;Canada;Netherlands;Germany;Japan;China;Korea, Republic of | |||
| 25 | EUCTR2010-024252-29-FI (EUCTR) | 01/04/2011 | 04/02/2011 | 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) | 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 Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 485 | Portugal;Greece;Finland;Spain;Netherlands;Germany | |||
| 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 |
| 26 | NCT01335464 (ClinicalTrials.gov) | April 2011 | 13/4/2011 | Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients | 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) | Pulmonary Fibrosis | Drug: placebo;Drug: BIBF 1120 | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 515 | Phase 3 | United States;Australia;Belgium;China;Czech Republic;France;Germany;India;Ireland;Israel;Italy;Japan;United Kingdom;Argentina;Brazil |
| 27 | EUCTR2009-013788-21-BG (EUCTR) | 05/10/2010 | 18/08/2010 | 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 | 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: 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 KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 28 | EUCTR2009-013788-21-IE (EUCTR) | 05/08/2010 | 20/05/2010 | 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 | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 29 | EUCTR2009-013788-21-CZ (EUCTR) | 02/08/2010 | 28/07/2010 | study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis | 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 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 KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;Greece;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany | ||
| 30 | EUCTR2009-013788-21-GR (EUCTR) | 14/07/2010 | 15/11/2010 | 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 | 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: 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 AE | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 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 |
| 31 | NCT01170065 (ClinicalTrials.gov) | June 25, 2010 | 6/7/2010 | Roll 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 Fibrosis | Pulmonary Fibrosis | Drug: BIBF 1120 | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 198 | Phase 2 | Argentina;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 |
| 32 | EUCTR2009-013788-21-HU (EUCTR) | 16/06/2010 | 05/07/2010 | 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 Fibrosis | 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 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 KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 33 | EUCTR2009-013788-21-GB (EUCTR) | 04/06/2010 | 11/10/2010 | 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 | 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 | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;Italy;United Kingdom | ||
| 34 | EUCTR2009-013788-21-DE (EUCTR) | 27/05/2010 | 22/04/2010 | Roll 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;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 | ||
| 35 | EUCTR2009-013788-21-PT (EUCTR) | 10/05/2010 | 18/03/2010 | 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 | 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: 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. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;Portugal;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 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 |
| 36 | NCT01136174 (ClinicalTrials.gov) | May 2010 | 31/5/2010 | Safety and PK Study of BIBF 1120 in Japanese Patients With IPF | A 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 Fibrosis | Drug: Placebo;Drug: BIBF 1120 | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 50 | Phase 2 | Japan |
| 37 | EUCTR2009-013788-21-ES (EUCTR) | 28/04/2010 | 23/02/2010 | Ensayo 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 | Ensayo 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. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 38 | EUCTR2009-013788-21-BE (EUCTR) | 22/04/2010 | 08/03/2010 | 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 | 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: 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.V | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 39 | EUCTR2009-013788-21-FR (EUCTR) | 09/04/2010 | 08/03/2010 | 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 | 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: 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 France | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Hungary;Portugal;United Kingdom;Czech Republic;Germany;Belgium;Bulgaria;France;Ireland;Spain;Italy;Greece | ||
| 40 | EUCTR2009-013788-21-IT (EUCTR) | 07/04/2010 | 26/03/2010 | 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 Fibrosis - ND | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy | ||
| 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 |
| 41 | EUCTR2006-002875-42-BG (EUCTR) | 12/05/2008 | 09/05/2008 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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 mbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;France;Bulgaria;Spain;Ireland;Italy;Greece | |||
| 42 | EUCTR2006-002875-42-GR (EUCTR) | 22/01/2008 | 20/09/2007 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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 | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 43 | EUCTR2006-002875-42-PT (EUCTR) | 11/01/2008 | 12/09/2007 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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 | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 44 | EUCTR2006-002875-42-CZ (EUCTR) | 19/12/2007 | 10/07/2007 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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 mbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Greece;Spain;Ireland;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany;Netherlands | |||
| 45 | EUCTR2006-002875-42-GB (EUCTR) | 20/11/2007 | 14/10/2010 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Portugal;Greece;Spain;Ireland;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | |||
| 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 |
| 46 | EUCTR2006-002875-42-HU (EUCTR) | 26/09/2007 | 27/06/2007 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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 KG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 47 | EUCTR2006-002875-42-IE (EUCTR) | 11/09/2007 | 12/06/2007 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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 | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 48 | EUCTR2006-002875-42-FR (EUCTR) | 23/08/2007 | 26/07/2007 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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 SAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 49 | EUCTR2006-002875-42-ES (EUCTR) | 20/08/2007 | 19/06/2007 | 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. | 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. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Ireland;Spain;Italy;Greece | |||
| 50 | EUCTR2006-002875-42-BE (EUCTR) | 14/08/2007 | 24/05/2007 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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.V | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 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 |
| 51 | NCT00514683 (ClinicalTrials.gov) | August 2007 | 9/8/2007 | Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis | 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. | Pulmonary Fibrosis | Drug: 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: placebo | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 432 | Phase 2 | Argentina;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 |
| 52 | EUCTR2006-002875-42-IT (EUCTR) | 17/07/2007 | 09/08/2007 | 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. | 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. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;France;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Netherlands;Germany;United Kingdom;Italy | |||
| 53 | EUCTR2006-002875-42-NL (EUCTR) | 16/07/2007 | 04/06/2007 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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 bv | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;France;Spain;Ireland;Italy;Greece | |||
| 54 | EUCTR2006-002875-42-DE (EUCTR) | 06/07/2007 | 08/05/2007 | 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. - Effect of orally administered BIBF 1120 on FVC decline in IPF | 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. - 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 | NULL | Not Recruiting | Female: yes Male: yes | 400 | Portugal;France;Hungary;Greece;Spain;Belgium;Ireland;Bulgaria;Netherlands;Germany;United Kingdom;Italy |