85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
| 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 | NCT05195918 (ClinicalTrials.gov) | March 1, 2023 | 2/12/2021 | Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients | Dose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug Effect | Idiopathic Pulmonary Fibrosis | Combination Product: EGCG 300 mg + Nintedanib;Combination Product: EGCG 300 mg + Pirfenidone;Combination Product: Placebo 2 capsules + Nintedanib or Pirfenidone;Combination Product: EGCG 600 mg + Nintedanib;Combination Product: EGCG 600 mg + Pirfenidone;Combination Product: Placebo 4 capsules + Nintedanib or Pirfenidone | Hal Chapman | University of Michigan;Cornell University;Massachusetts General Hospital;Temple University;University of Washington | Not yet recruiting | 40 Years | 85 Years | All | 50 | Phase 1 | United States |
| 2 | NCT05373914 (ClinicalTrials.gov) | May 31, 2022 | 10/5/2022 | RESPIRARE - Efficacy and Safety of Cudetaxestat in Patients With Idiopathic Pulmonary Fibrosis (IPF) | RESPIRARE - A Phase 2, Randomized, Double-blinded, Placebo-controlled, Efficacy and Safety Study of Cudetaxestat (BLD-0409) Assessed Across Three Dose Ranges With or Without Standard of Care (Nintedanib or Pirfenidone) in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Cudetaxestat (BLD-0409);Drug: Control: Matching Placebo | Blade Therapeutics | NULL | Not yet recruiting | 40 Years | 85 Years | All | 200 | Phase 2 | NULL |
| 3 | NCT04888715 (ClinicalTrials.gov) | July 23, 2021 | 28/4/2021 | To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers | An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers | Idiopathic Pulmonary Fibrosis | Drug: DWN12088;Drug: Pirfenidone;Drug: Nintedanib | Daewoong Pharmaceutical Co. LTD. | NULL | Completed | 19 Years | 55 Years | All | 48 | Phase 1 | Korea, Republic of |
| 4 | NCT05383131 (ClinicalTrials.gov) | June 23, 2021 | 12/5/2022 | To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers | A Single Center, Open Label Study to Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers | Idiopathic Pulmonary Fibrosis | Drug: HEC585;Drug: Pirfenidone;Drug: Nintedanib | Sunshine Lake Pharma Co., Ltd. | NULL | Completed | 18 Years | 45 Years | All | 33 | Phase 1 | China |
| 5 | 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 | No longer available | 18 Years | N/A | All | Belgium | ||
| 6 | JPRN-jRCT2031210008 | 27/01/2021 | 02/04/2021 | A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care | A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | This clinical Phase 3 study is a randomized, double-blind, parallel-group, placebo-controlled multicenter study designed to evaluate the efficacy and safety of two doses (200 mg q.d. and 600 mg q.d.) of orally administered GLPG1690 in addition to local standard of care for at least 52 weeks in adult subjects with a centrally confirmed diagnosis of IPF. Local standard of care for IPF is defined as receiving either pirfenidone or nintedanib at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months. A total of approximately 750 subjects with confirmed diagnosis of IPF will be randomized, 250 subjects in each treatment group (GLPG1690 600 mg q.d., GLPG1690200 mg q.d., or matching placebo). | Kayamori Takefumi | NULL | Not Recruiting | >= 40age old | Not applicable | Both | 49 | Phase 3 | Japan;USA;Denmark;Peru;Australia;Germany;Taiwan;Belgium;Greece;Brazil;Spain;Chile;United Kingdom;Czech Republic;Turkey |
| 7 | 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 | Completed | N/A | N/A | All | 70 | Korea, Republic of | |
| 8 | 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 | Active, not recruiting | 20 Years | N/A | All | 214 | Taiwan | |
| 9 | NCT03939520 (ClinicalTrials.gov) | June 11, 2020 | 3/5/2019 | Management of Progressive Disease in Idiopathic Pulmonary Fibrosis | Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized Trial | Progressive Idiopathic Pulmonary Fibrosis | Drug: pirfenidone and nintedanib;Drug: pirfenidone or nintedanib | Hospices Civils de Lyon | NULL | Recruiting | 50 Years | N/A | All | 378 | Phase 4 | France |
| 10 | EUCTR2019-004326-19-FR (EUCTR) | 27/01/2020 | 13/11/2019 | Management of Progressive Disease in Idiopathic Pulmonary Fibrosis | Pragmatic management of progressive disease in idiopathic pulmonary fibrosis: a randomized trial - PROGRESSION-IPF | Idiopathic pulmonary fibrosis 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: pirfenidone INN or Proposed INN: PIRFENIDONE Trade Name: nintedanib Other descriptive name: NINTEDANIB | Hospices Civils de Lyon | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 378 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 11 | JPRN-UMIN000039027 | 2019/12/26 | 27/12/2019 | Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS) | Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS) - J-AVENGERS | idiopathic pulmonary fibrosis | 48 weeks of observational period, administration of nintedanib, 100mg or 150mg twice a day and pirfenidone, 200mg, 400mg, or 600mg 3 times a day | Japanese Red Cross Medical Canter | NULL | Recruiting | 40years-old | Not applicable | Male and Female | 35 | Not selected | Japan |
| 12 | JPRN-jRCTs031190119 | 28/10/2019 | 18/10/2019 | A phase II Study of CBDCA + ETP + Nintedanib for SCLC with IPF | A Phase II Study of Carboplatin and Etoposide Plus Nintedanib for Unresectable Limited/Extensive Disease Small Cell Lung Cancer with Idiopathic Pulmonary Fibrosis - TORG1835 / NEXT-SHIP | Unresectable limited or extensive disease small cell lung cancer with idiopathic pulmonary fibrosis | The patients receive carboplatin(area under the curve 5 mg/mL, intravenously, day 1), etoposide (<75 years old:100mg/m2:>=75years old:80mg/m2;intravenously,days 1-3), and nintedanib (150mg twice a day, orally). The patients receive combination chemotherapy every3 weeks for 4 cycles until disease progression or unacceptable toxicity occurs. After completion or discontinuation of carboplatin plus etoposide, the patients continue nintedanib until the discontinuation criteria are satisfied. | IKEDA Satoshi | OGURA Takashi;Thoracic Oncology Research Group | Not Recruiting | >= 20age old | Not applicable | Both | 33 | Phase 2 | Japan |
| 13 | NCT03562416 (ClinicalTrials.gov) | July 5, 2019 | 7/5/2018 | Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects | Nintedanib Plus Usual Transplant Care Compared to Usual Transplant Care Alone After Single Lung Transplantation in Patients With Idiopathic Pulmonary Fibrosis: a Pilot Randomized Controlled Trial | Idiopathic Pulmonary Fibrosis;Lung Transplant; Complications | Drug: Nintedanib;Drug: Placebo Oral Tablet | Temple University | Boehringer Ingelheim | Recruiting | 35 Years | 70 Years | All | 20 | Phase 2 | United States |
| 14 | NCT03710824 (ClinicalTrials.gov) | February 28, 2019 | 16/10/2018 | Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib | Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib | Boehringer Ingelheim | NULL | Active, not recruiting | 40 Years | N/A | All | 180 | Greece | |
| 15 | NCT03958071 (ClinicalTrials.gov) | February 1, 2019 | 20/5/2019 | A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking | Characteristics of IPF Patients Initiating Nintedanib, Pirfenidone or no Antifibrotic Treatment in the US | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Drug: Pirfenidone;Other: Untreated Cohort | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 13264 | United States | |
| 16 | NCT03717012 (ClinicalTrials.gov) | November 15, 2018 | 19/10/2018 | Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoL | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Other: Pulmonary rehabilitation program | Boehringer Ingelheim | NULL | Terminated | 40 Years | N/A | All | 19 | Phase 4 | United States |
| 17 | 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 | |
| 18 | JPRN-UMIN000026376 | 2017/09/01 | 03/03/2017 | Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis | Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis - Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in IPF | Idiopathic pulmonary fibrosis(IPF) | Short-term induction pulmonary rehabilitation (2/1w for the first 12w) + Maintenance pulmonary rehabilitation and outpatient visit (1/4w) Total 52w. / No intervention Nintedanib / both group | Central Japan Lung Study Grou | NULL | Complete: follow-up complete | 40years-old | 80years-old | Male and Female | 84 | Phase 4 | Japan |
| 19 | 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 | ||
| 20 | JPRN-jRCTs071180049 | 23/05/2017 | 15/03/2019 | Japanese Intergroup Study of Nintedanib for NSCLC with IPF | A randomized phase III study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis - J-SONIC | Advanced Non-small cell lung cancer with idiopathic pulmonary fibrosis | carboplatin + nab-paclitaxel carboplatin + nab-paclitaxel + nintedanib | Okamoto Isamu | Otsubo Kohei | Complete | >= 20age old | Not applicable | Both | 240 | Phase 3 | Japan |
| 21 | JPRN-UMIN000026799 | 2017/05/12 | 01/04/2017 | A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis | A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis - Japanese Intergroup Study of Nintedanib for NSCLC with IPF (J-SONIC) | Non-small-cell lung cancer with idiopathic pulmonary fibrosis | A: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) repeated every 3 weeks B: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) in combination with nintedanib (150 mg B.I.D, daily) repeated every 3 weeks followed by single-agent administration of nintedanib (150 mg B.I.D, daily) | Research Institute for Diseases of the Chest, Kyushu University | NULL | Complete: follow-up continuing | 20years-old | Not applicable | Male and Female | 240 | Phase 3 | Japan |
| 22 | 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 | ||
| 23 | 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 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | NCT02802345 (ClinicalTrials.gov) | June 30, 2016 | 14/6/2016 | Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment | INSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function Impairment | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Drug: Placebo;Drug: Sildenafil | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 274 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Spain;United Kingdom |
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | NCT02788474 (ClinicalTrials.gov) | June 9, 2016 | 27/5/2016 | Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment | 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. | Idiopathic Pulmonary Fibrosis | Drug: nintedanib;Drug: placebo | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 347 | Phase 4 | United States;Australia;Belgium;Czechia;Finland;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Spain;United Kingdom;Czech Republic |
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 | ||
| 39 | NCT02606877 (ClinicalTrials.gov) | April 19, 2016 | 16/11/2015 | A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination | Investigation of Drug-drug Interaction Between Nintedanib and Pirfenidone in Patients With IPF (an Open Label, Multiple-dose, Two Group Study) | Idiopathic Pulmonary Fibrosis | Drug: nintedanib;Drug: pirfenidone | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 37 | Phase 4 | United Kingdom |
| 40 | JPRN-UMIN000021591 | 2016/04/04 | 01/04/2016 | The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia | The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia - The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia | Advanced non-small cell lung cancer with idiopathic interstitial pneumonia | carboplatin AUC6 D1 paclitaxel 200mg/m D1 tryweekly 4cycle nintedanib 150mg twice daily | Hirosaki University Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 41 | 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 | ||
| 42 | JPRN-UMIN000020722 | 2016/01/26 | 25/01/2016 | Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis | Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis - The CT study with Nintedanib | idiopathic pulmonary fibrosis | administration of 150mg of nintedanib twice daily | Kanagawa Cardiovascular and Respiratory Center | NULL | Recruiting | 40years-old | Not applicable | Male and Female | 30 | Not applicable | Japan |
| 43 | JPRN-UMIN000020682 | 2016/01/22 | 22/01/2016 | The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis | The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis - The comparison of antifibrotic agents in patients with idiopathic pulmonary fibrosis | Idiopathic pulmonary fibrosis | pirfenidone 12 months 200-600mg t.i.d or b.i.d nintedanib 12 months 100-150mg b.i.d | National Hospital Organization Ibarakihigashi National HospitalThe center of Chest Diseases and Severe Motor&Intellectual Disabilities | NULL | Pending | 20years-old | Not applicable | Male and Female | 60 | Not applicable | Japan |
| 44 | 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 | ||
| 45 | 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 |
| 46 | 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 | ||
| 47 | 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 | ||
| 48 | 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 | ||
| 49 | 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 | ||
| 50 | JPRN-UMIN000019436 | 2015/10/16 | 21/10/2015 | Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone | Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone - Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone | idiopathic pulmonary fibrosis | Nintedanib+pirfenidone group; Nintedanib 150mg twice daily Pirfenidone 600-1800mg/day Nintedanib group; Nintedanib 150mg twice daily | Kanagawa Cardiovascular and Respiratory Center | NULL | Complete: follow-up complete | 40years-old | Not applicable | Male and Female | 60 | Phase 2 | Japan |
| 51 | NCT02579603 (ClinicalTrials.gov) | October 16, 2015 | 16/10/2015 | 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) | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Drug: Pirfenidone | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 105 | Phase 4 | United States;Canada;France;Germany;Italy;Netherlands |
| 52 | 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 | ||
| 53 | 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 | |
| 54 | 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 | ||
| 55 | NCT02230982 (ClinicalTrials.gov) | November 12, 2014 | 29/8/2014 | Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis | Multi-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: nintedanib | Boehringer Ingelheim | NULL | No longer available | 40 Years | N/A | All | Brazil | ||
| 56 | NCT02171156 (ClinicalTrials.gov) | May 2014 | 18/6/2014 | Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP) | Multi-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: nintedanib | Boehringer Ingelheim | NULL | Approved for marketing | 40 Years | N/A | All | N/A | United States | |
| 57 | NCT01979952 (ClinicalTrials.gov) | November 26, 2013 | 4/11/2013 | Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF) | A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen Months | Idiopathic Pulmonary Fibrosis | Drug: Matching Placebo;Drug: Nintedanib | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 113 | Phase 3 | United States;Canada;Turkey |
| 58 | NCT01890265 (ClinicalTrials.gov) | July 30, 2013 | 24/6/2013 | Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Pamrevlumab;Drug: Placebo;Drug: Sub-Study: Pirfenidone;Drug: Sub-Study: Nintedanib | FibroGen | NULL | Completed | 40 Years | 80 Years | All | 160 | Phase 2 | United States;Australia;Bulgaria;Canada;India;New Zealand;South Africa |
| 59 | EUCTR2011-002766-21-IE (EUCTR) | 23/04/2013 | 15/02/2013 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 60 | EUCTR2011-002766-21-CZ (EUCTR) | 03/08/2012 | 19/06/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 61 | EUCTR2011-002766-21-IT (EUCTR) | 25/07/2012 | 19/06/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Chile;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;China;Japan;Korea, Republic of | ||
| 62 | EUCTR2011-002766-21-DE (EUCTR) | 02/07/2012 | 04/05/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 63 | EUCTR2011-002766-21-BE (EUCTR) | 26/06/2012 | 26/04/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | SCS Boehringer Ingelheim Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 64 | EUCTR2011-002766-21-ES (EUCTR) | 18/06/2012 | 26/04/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim España S.A | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Russian Federation;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 65 | EUCTR2011-002766-21-GB (EUCTR) | 15/06/2012 | 21/05/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) - | Idiopathic Pulmonary Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 66 | EUCTR2011-002766-21-FI (EUCTR) | 06/06/2012 | 16/05/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 67 | EUCTR2011-002766-21-GR (EUCTR) | 02/05/2012 | 11/04/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim Hellas | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Chile;Russian Federation;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 68 | EUCTR2011-002766-21-PT (EUCTR) | 20/04/2012 | 20/04/2012 | Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Unilfarma - União Internacional de Lab. Farmacêuticos, Lda | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan | ||
| 69 | NCT01417156 (ClinicalTrials.gov) | September 2011 | 15/8/2011 | Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174) | A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary Fibrosis | Pulmonary Fibrosis | Drug: Nintedanib;Drug: Pirfenidoneone | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 20 | Phase 2 | Japan |
| 70 | EUCTR2009-013788-21-CZ (EUCTR) | 02/08/2010 | 28/07/2010 | study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: nintedanib | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;Greece;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany | ||
| 71 | EUCTR2009-013788-21-HU (EUCTR) | 16/06/2010 | 05/07/2010 | A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis | A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: Not applicable Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: Not applicable Product Name: BIBF 1120 Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: Not applicable | Boehringer Ingelheim RCV GmBH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy |