85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details
臨床試験数 : 598 / 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 |