BI 1015550 ( DrugBank: - )
1 disease
告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
85 | 特発性間質性肺炎 | 14 |
85. 特発性間質性肺炎
臨床試験数 : 598 / 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | EUCTR2019-004167-45-CZ (EUCTR) | 12/04/2021 | 18/06/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
2 | EUCTR2019-004167-45-GR (EUCTR) | 17/12/2020 | 03/12/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | |||
3 | EUCTR2019-004167-45-SK (EUCTR) | 02/11/2020 | 11/08/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
4 | EUCTR2019-004167-45-AT (EUCTR) | 23/10/2020 | 06/07/2020 | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
5 | EUCTR2019-004167-45-DK (EUCTR) | 27/08/2020 | 12/06/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim B.V. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
6 | EUCTR2019-004167-45-PL (EUCTR) | 24/08/2020 | 14/07/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Germany;Japan;Poland;Argentina;Canada;Mexico;Czech Republic;Hungary;United Kingdom;Austria;Finland;Czechia;Korea, Republic of;China;Netherlands;Australia;Denmark;France;Italy;Russian Federation;Chile;Ukraine;Spain;Greece;Slovakia;United States | ||
7 | EUCTR2019-004167-45-GB (EUCTR) | 19/08/2020 | 24/06/2020 | A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;Chile;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of | ||
8 | EUCTR2019-004167-45-HU (EUCTR) | 17/08/2020 | 24/06/2020 | A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 18 mg taken orally b.i.d. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Russian Federation;Chile;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
9 | EUCTR2019-004167-45-DE (EUCTR) | 30/07/2020 | 22/06/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
10 | NCT04419506 (ClinicalTrials.gov) | July 28, 2020 | 4/6/2020 | A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) | A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally | Idiopathic Pulmonary Fibrosis | Drug: BI 1015550;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 147 | Phase 2 | United States;Argentina;Australia;Austria;Canada;Chile;China;Czechia;Denmark;Finland;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
11 | EUCTR2019-004167-45-IT (EUCTR) | 09/07/2020 | 17/06/2021 | A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. - - | 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] | Product Name: - Product Code: [BI 1015550] Other descriptive name: BI 1015550 Product Name: - Product Code: [BI 1015550] Other descriptive name: BI 1015550 | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | United States;Czechia;Slovakia;Greece;Finland;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of | ||
12 | EUCTR2019-004167-45-NL (EUCTR) | 09/07/2020 | 12/05/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Italy;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
13 | EUCTR2019-004167-45-FI (EUCTR) | 18/05/2020 | 15/04/2020 | A study to test how taking BI 1015550 for 12 weeks affects lungfunction in people with idiopathic pulmonary fibrosis (IPF). | A randomised, double-blind, placebo-controlled parallel groupstudy in IPF patients over 12 weeks evaluating efficacy, safety andtolerability of BI 1015550 taken orally. | 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] | Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 Product Code: BI 1015550 INN or Proposed INN: BI 1015550 Other descriptive name: BI 1015550 | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Italy;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Germany;Japan | ||
14 | NCT03422068 (ClinicalTrials.gov) | March 16, 2018 | 22/1/2018 | This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated. | Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic Therapy. | Idiopathic Pulmonary Fibrosis | Drug: BI 1015550;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 15 | Phase 1 | Belgium;Denmark;Finland;Germany;Italy;Netherlands;Spain;United Kingdom;France |