BI 1015550 18 mg Film Coated Tablet ( 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4

85. 特発性間質性肺炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2022-001091-34-DK
(EUCTR)
26/01/202313/12/2022A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - PDE4 Phase III trial in IPF (Fibroneer- IPF) 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]
Product Name: BI 1015550 9 mg Film Coated Tablet
Product Code: BI 1015550
Other descriptive name: BI 1015550
Product Name: BI 1015550 18 mg Film Coated Tablet
Product Code: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim FranceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
963Phase 3Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden
2EUCTR2022-001091-34-GR
(EUCTR)
21/12/202202/11/2022A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - PDE4 Phase III trial in IPF (Fibroneer- IPF) 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]
Product Name: BI 1015550 9 mg Film Coated Tablet
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Product Name: BI 1015550 18 mg Film Coated Tablet
Product Code: BI 1015550
INN or Proposed INN: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim B.VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
963Phase 3Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden
3EUCTR2022-001091-34-IE
(EUCTR)
19/12/202228/07/2022A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - FIBRONEER-IPF 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]
Product Name: BI 1015550 9 mg Film Coated Tablet
Product Code: BI 1015550
Other descriptive name: BI 1015550
Product Name: BI 1015550 18 mg Film Coated Tablet
Product Code: BI 1015550
Other descriptive name: BI 1015550
Boehringer Ingelheim International GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
963Phase 3Germany;Japan;New Zealand;Sweden;Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway
4EUCTR2022-001091-34-NL
(EUCTR)
05/12/202213/10/2022A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)A double blind, randomized, placebo-controlled trial evaluatingthe efficacy and safety of BI 1015550 over at least 52 weeks inpatients with Idiopathic Pulmonary Fibrosis (IPF) - PDE4 Phase III trial in IPF (Fibroneer- IPF) 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]
Product Name: BI 1015550 9 mg Film Coated Tablet
Product Code: BI 1015550
INN or Proposed INN: Not assigned yet
Other descriptive name: BI 1015550
Product Name: BI 1015550 18 mg Film Coated Tablet
Product Code: BI 1015550
INN or Proposed INN: Not assigned yet
Other descriptive name: BI 1015550
Boehringer Ingelheim BV NetherlandsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
963Phase 3Serbia;Portugal;United States;Saudi Arabia;Taiwan;Estonia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden