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 | EUCTR2015-005131-40-CZ (EUCTR) | 20/03/2017 | 16/12/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) 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: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 2 | EUCTR2015-005131-40-HU (EUCTR) | 16/01/2017 | 01/12/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with 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: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Hungary;Czech Republic;Canada;Belgium;South Africa;Netherlands;Germany | ||
| 3 | EUCTR2015-005131-40-BE (EUCTR) | 16/12/2016 | 20/10/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with 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 Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 4 | EUCTR2015-005131-40-DE (EUCTR) | 08/12/2016 | 25/10/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Addedto Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis andRisk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLEDSTUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTSWITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with 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 Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 5 | EUCTR2015-005131-40-GR (EUCTR) | 06/12/2016 | 03/11/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with 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: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 6 | EUCTR2015-005131-40-NL (EUCTR) | 02/12/2016 | 13/10/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Risk of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) 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: Esbriet Product Name: Esbriet Product Code: RO0220912 INN or Proposed INN: PIRFENIDONE Trade Name: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Netherlands;Germany | ||
| 7 | EUCTR2015-005131-40-ES (EUCTR) | 20/10/2016 | 09/09/2016 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease. | A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTS WITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND INTERMEDIATE OR HIGH PROBABILITY OF GROUP 3 PULMONARY HYPERTENSION. | Pulmonary Hypertension in patients with 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: Sildenafil Product Name: Sildenafil Product Code: RO0280296 INN or Proposed INN: SILDENAFIL | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 2 | United Arab Emirates;Greece;Spain;Turkey;Israel;Italy;Egypt;Czech Republic;Hungary;Canada;Belgium;South Africa;Germany;Netherlands | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 |