OFEV ( DrugBank: - )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 51 | 全身性強皮症 | 32 |
| 85 | 特発性間質性肺炎 | 30 |
| 89 | リンパ脈管筋腫症 | 1 |
| 227 | オスラー病 | 1 |
| 228 | 閉塞性細気管支炎 | 1 |
51. 全身性強皮症
臨床試験数 : 523 / 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
| 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 | NCT04325217 (ClinicalTrials.gov) | April 15, 2020 | 26/3/2020 | Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan | Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan | Lung Diseases, Interstitial | Drug: Nintedanib | Boehringer Ingelheim | NULL | Recruiting | N/A | N/A | All | 600 | Japan | |
| 2 | EUCTR2016-003403-66-SE (EUCTR) | 15/10/2018 | 14/05/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 3 | EUCTR2016-003403-66-IT (EUCTR) | 28/09/2018 | 14/06/2021 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS(TM)- ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: [BIBF 1120] INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: [BIBF 1120] INN or Proposed INN: NINTEDANIB | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 4 | EUCTR2016-003403-66-GR (EUCTR) | 21/09/2018 | 14/05/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim B.V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 5 | EUCTR2016-003403-66-FI (EUCTR) | 17/07/2018 | 29/06/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R) -ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Fnland Ky | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 6 | EUCTR2016-003403-66-CZ (EUCTR) | 20/06/2018 | 12/04/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 7 | EUCTR2016-003403-66-AT (EUCTR) | 17/04/2018 | 28/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 8 | EUCTR2016-003403-66-BE (EUCTR) | 12/04/2018 | 12/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM) Extension | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | SCS Boehringer Ingelheim Comm. V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 9 | EUCTR2016-003403-66-DK (EUCTR) | 05/04/2018 | 02/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R)-on | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 10 | EUCTR2016-003403-66-FR (EUCTR) | 04/04/2018 | 01/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim France | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 11 | EUCTR2016-003403-66-PT (EUCTR) | 23/02/2018 | 13/12/2017 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Unilfarma - União Internacional de Lab. Farmacêuticos, Lda. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Norway;Japan;Sweden;United States;Portugal;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany | ||
| 12 | EUCTR2016-003403-66-GB (EUCTR) | 07/02/2018 | 09/01/2018 | A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 13 | EUCTR2016-003403-66-ES (EUCTR) | 19/01/2018 | 22/11/2017 | A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim España, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 14 | EUCTR2016-003403-66-NL (EUCTR) | 06/11/2017 | 27/09/2017 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim bv | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 15 | EUCTR2015-000392-28-CZ (EUCTR) | 27/06/2017 | 27/04/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 16 | EUCTR2015-000392-28-HU (EUCTR) | 08/06/2017 | 26/04/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 17 | EUCTR2015-000392-28-NO (EUCTR) | 02/06/2017 | 15/02/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Norway KS | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Norway;Germany;Japan;Sweden | ||
| 18 | EUCTR2015-000392-28-AT (EUCTR) | 12/05/2017 | 31/03/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Belgium;Norway;Germany;Japan;Sweden;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia | ||
| 19 | EUCTR2015-000392-28-SE (EUCTR) | 08/05/2017 | 24/02/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden;Switzerland;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel | ||
| 20 | EUCTR2015-000392-28-FI (EUCTR) | 21/02/2017 | 10/02/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 21 | EUCTR2015-000392-28-IE (EUCTR) | 27/06/2016 | 13/04/2016 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 22 | EUCTR2015-000392-28-PL (EUCTR) | 09/03/2016 | 21/01/2016 | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim RCV GmbH&Co KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 23 | EUCTR2015-000392-28-PT (EUCTR) | 08/01/2016 | 14/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Unilfarma - União Internacional de Lab. Farmacêuticos, Lda | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 24 | EUCTR2015-000392-28-IT (EUCTR) | 23/12/2015 | 08/06/2021 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - SENSCIS¿ | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;Classification code 10012977;Term: Diffuse systemic sclerosis;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 25 | EUCTR2015-000392-28-FR (EUCTR) | 11/12/2015 | 14/12/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 18.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 26 | EUCTR2015-000392-28-BE (EUCTR) | 08/12/2015 | 25/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden;United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China | ||
| 27 | EUCTR2015-000392-28-ES (EUCTR) | 19/11/2015 | 05/10/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 28 | EUCTR2015-000392-28-GR (EUCTR) | 18/11/2015 | 22/10/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Ellas SA | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 29 | EUCTR2015-000392-28-DE (EUCTR) | 11/11/2015 | 25/08/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 30 | EUCTR2015-000392-28-GB (EUCTR) | 10/11/2015 | 01/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 31 | EUCTR2015-000392-28-NL (EUCTR) | 02/11/2015 | 24/08/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 32 | EUCTR2015-000392-28-DK (EUCTR) | 22/09/2015 | 22/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden |
85. 特発性間質性肺炎
臨床試験数 : 598 / 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04739150 (ClinicalTrials.gov) | March 29, 2021 | 1/2/2021 | An Expanded Access Program in Belgium to Provide Nintedanib to People With Lung Diseases Called Non-IPF ILDs Who Have no Alternative Treatment Options | Medical Need Program With Ofev® (Nintedanib) for the Treatment of Adult Patients With Non-IPF (Idiopathic Pulmonary Fibrosis) Chronic Fibrosing Interstitial Lung Diseases (ILDs) With a Progressive Phenotype (PF-ILD's) | Lung Diseases, Interstitial | Drug: nintedanib | Boehringer Ingelheim | NULL | Available | 18 Years | N/A | All | Belgium | ||
| 2 | NCT04525547 (ClinicalTrials.gov) | January 13, 2021 | 21/8/2020 | Safety and Effectiveness of Nintedanib in Korean Patients | A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib | Boehringer Ingelheim | NULL | Recruiting | N/A | N/A | All | 3000 | Korea, Republic of | |
| 3 | NCT04614441 (ClinicalTrials.gov) | December 25, 2020 | 29/10/2020 | NICEFIT-ON: A Study Under Routine Clinical Practice in Taiwan to Observe the Long-term Outcome of People With Certain Types of Lung Disease (PF-ILD, SSc-ILD, IPF) Who Start Treatment With Nintedanib. | Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy | Idiopathic Pulmonary Fibrosis | Drug: OFEV® | Boehringer Ingelheim | NULL | Recruiting | 20 Years | N/A | All | 500 | Taiwan | |
| 4 | NCT03281200 (ClinicalTrials.gov) | October 24, 2017 | 11/9/2017 | Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain | A Multicentre, Retrospective Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain. | Idiopathic Pulmonary Fibrosis | Drug: L - Antineoplastic and immunomodulating agents;Drug: L01 - Antineoplastic agents;Drug: L01X - Other antineoplastic agents;Drug: L01XE - Protein kinase inhibitors;Drug: L01XE31 - Nintedanib | Boehringer Ingelheim | NULL | Completed | 18 Years | N/A | All | 172 | Spain | |
| 5 | EUCTR2015-002619-14-FR (EUCTR) | 21/06/2017 | 25/04/2018 | Efficacy and safety of nintedanib co-administered with sildenafil in IPF patients with advanced lung function impairment | A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Italy;United Kingdom;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 6 | EUCTR2015-003148-38-PL (EUCTR) | 08/11/2016 | 04/10/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of | ||
| 7 | EUCTR2015-002619-14-IT (EUCTR) | 01/09/2016 | 04/06/2021 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE(TM):A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 21.1;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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: Nintedanib Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: Nintedanib Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 8 | EUCTR2015-002619-14-GB (EUCTR) | 01/08/2016 | 08/09/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 9 | EUCTR2015-002619-14-BE (EUCTR) | 25/07/2016 | 03/06/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE (TM) : A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE (TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 10 | EUCTR2015-002619-14-DE (EUCTR) | 21/07/2016 | 04/05/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 11 | EUCTR2015-003148-38-DE (EUCTR) | 14/07/2016 | 20/05/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 490 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 12 | EUCTR2015-002619-14-ES (EUCTR) | 29/06/2016 | 17/05/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
| 13 | EUCTR2015-003148-38-ES (EUCTR) | 13/06/2016 | 11/03/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 18.1;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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 14 | EUCTR2015-003148-38-BE (EUCTR) | 06/06/2016 | 19/04/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 15 | EUCTR2015-003148-38-GB (EUCTR) | 06/06/2016 | 18/04/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 490 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 16 | EUCTR2015-003148-38-HU (EUCTR) | 27/05/2016 | 12/04/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 18.1;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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 17 | EUCTR2015-003148-38-CZ (EUCTR) | 26/05/2016 | 11/04/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | MedDRA version: 18.1;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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of;United States | ||
| 18 | EUCTR2015-003148-38-FR (EUCTR) | 24/05/2016 | 04/05/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 19 | EUCTR2015-003148-38-FI (EUCTR) | 17/05/2016 | 12/04/2016 | Effect of nintedanib on biomarkers | A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment. | 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 4 | United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of | ||
| 20 | EUCTR2015-003280-11-NL (EUCTR) | 29/04/2016 | 19/01/2016 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) 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] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Germany;Netherlands;Italy | ||
| 21 | EUCTR2015-003280-11-DE (EUCTR) | 25/02/2016 | 19/10/2015 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) 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] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 22 | EUCTR2015-003280-11-DK (EUCTR) | 20/01/2016 | 25/11/2015 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) 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] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 23 | NCT02598193 (ClinicalTrials.gov) | January 14, 2016 | 4/11/2015 | Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF) | An Exploratory Multicenter, Open-Label, Single Arm Study of the Safety and Tolerability of Pirfenidone (Esbriet®) in Combination With Nintedanib (Ofev®) in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Drug: Pirfenidone | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 89 | Phase 4 | United States;Canada;Denmark;France;Germany;Italy;Netherlands;Spain |
| 24 | EUCTR2015-000640-42-IT (EUCTR) | 22/12/2015 | 22/02/2018 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib incombination with oral pirfenidone, compared to treatment with nintedanib alone, 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] | Trade Name: Ofev INN or Proposed INN: nintedanib Other descriptive name: nintedanib Trade Name: Ofev INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | France;United States;Canada;Netherlands;Germany;Italy | ||
| 25 | EUCTR2015-003280-11-IT (EUCTR) | 17/12/2015 | 27/05/2021 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET¿) IN COMBINATION WITH NINTEDANIB (OFEV¿) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS - NA | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 21.1;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] | Trade Name: ESBRIET - 267 MG - CAPSULA RIGIDA - USO ORALE - FLACONE (HDPE) 270 CAPSULE Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev INN or Proposed INN: NINTEDANIB Trade Name: Ofev INN or Proposed INN: NINTEDANIB | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 26 | EUCTR2015-003280-11-ES (EUCTR) | 16/12/2015 | 30/10/2015 | A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis | AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 18.1;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] | Trade Name: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Ofev Product Code: 534-1508 INN or Proposed INN: NINTEDANIB | Roche Farma S.A., que representa en España a F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy | ||
| 27 | EUCTR2015-000640-42-DE (EUCTR) | 01/12/2015 | 03/09/2015 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib iin combination with pirfenidone in IPF | 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet Product Name: pirfenidone Product Code: pirfenidone INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | Boehringer Ingelheim Pharma GmbH & Co.KG | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | France;United States;Canada;Netherlands;Germany;Italy | ||
| 28 | EUCTR2015-000640-42-NL (EUCTR) | 13/10/2015 | 18/08/2015 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib iin combination with pirfenidone in IPF | Idiopathic Pulmonary Fibrosis MedDRA version: 18.1;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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet Product Name: pirfenidone Product Code: pirfenidone INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | France;United States;Canada;Germany;Netherlands;Italy | ||
| 29 | NCT02607722 (ClinicalTrials.gov) | August 31, 2015 | 2/9/2015 | All-Case Surveillance of Ofev in Patients With IPF in Japan | The Special Drug Use-results Survey (All-Case Surveillance) of Ofev® Capsules in Patients With Idiopathic Pulmonary Fibrosis (IPF) in Japan | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib | Boehringer Ingelheim | NULL | Recruiting | N/A | N/A | All | 6000 | Japan | |
| 30 | EUCTR2015-000640-42-FR (EUCTR) | 26/08/2015 | 05/08/2015 | Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF | A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib in combination with pirfenidone in 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] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Esbriet Product Name: pirfenidone Product Code: pirfenidone INN or Proposed INN: PIRFENIDONE Other descriptive name: PIRFENIDONE | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 4 | United States;France;Canada;Netherlands;Germany;Italy |
89. リンパ脈管筋腫症
臨床試験数 : 39 / 薬物数 : 46 - (DrugBank : 20) / 標的遺伝子数 : 27 - 標的パスウェイ数 : 137
| 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 | EUCTR2015-004919-20-IT (EUCTR) | 09/03/2016 | 11/08/2016 | A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) | A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) - A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) | Female subjects affected by Llymphangioleiomyomatosis (LAM) MedDRA version: 19.0;Level: PT;Classification code 10049459;Term: Lymphangioleiomyomatosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev | MULTIMEDICA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 30 | Phase 3 | Italy |
227. オスラー病
臨床試験数 : 54 / 薬物数 : 73 - (DrugBank : 21) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 136
| 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 | EUCTR2019-002593-31-FR (EUCTR) | 05/11/2019 | 05/09/2019 | Efficacy of Nintedanib per os as a treatment for epistaxis in HHT diseaseEPICURE | Efficacy of Nintedanib per os as a treatment for epistaxis in HHT diseaseA national, randomized, multicenter phase II studyEPICURE | Hereditary Hemorrhagic Telangiectasia MedDRA version: 20.1;Level: LLT;Classification code 10019887;Term: Hereditary hemorrhagic telangiectasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: OFEV Product Name: nintédanib Other descriptive name: NINTEDANIB | Hospices Civils de Lyon | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | France |
228. 閉塞性細気管支炎
臨床試験数 : 96 / 薬物数 : 125 - (DrugBank : 34) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 155
| 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 | EUCTR2018-001747-31-FR (EUCTR) | 09/04/2019 | 28/12/2018 | A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) recipients with bronchiolitis obliterans syndrome (BOS) grade 1-2 | A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Tranplant (LTx) recipients with bronchiolitis obliterans sydrome (BOS) grade 1-2 - INFINITX BOS | Bronchiolitis Obliterating Syndrome (SBO) grade 1 or 2 in patients with pulmonary transplantation. MedDRA version: 20.0;Level: PT;Classification code 10029888;Term: Obliterative bronchiolitis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: OFEV INN or Proposed INN: Nintedanib Other descriptive name: Nintedanib | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France |