Ofev 100 mg capsule ( 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18

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
1EUCTR2015-002619-14-FR
(EUCTR)
21/06/201725/04/2018Efficacy and safety of nintedanib co-administered with sildenafil in IPF patients with advanced lung function impairmentA 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 FranceNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Italy;United Kingdom;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
2EUCTR2015-003148-38-PL
(EUCTR)
08/11/201604/10/2016Effect of nintedanib on biomarkersA 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 KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of
3EUCTR2015-002619-14-IT
(EUCTR)
01/09/201604/06/2021Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
4EUCTR2015-002619-14-GB
(EUCTR)
01/08/201608/09/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(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 LimitedNULLNot 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): noUnited States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
5EUCTR2015-002619-14-BE
(EUCTR)
25/07/201603/06/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE (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. VNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
6EUCTR2015-002619-14-DE
(EUCTR)
21/07/201604/05/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(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. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
7EUCTR2015-003148-38-DE
(EUCTR)
14/07/201620/05/2016Effect of nintedanib on biomarkersA 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. KGNULLNot 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): yesUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
8EUCTR2015-002619-14-ES
(EUCTR)
29/06/201617/05/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentA 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
9EUCTR2015-003148-38-ES
(EUCTR)
13/06/201611/03/2016Effect of nintedanib on biomarkersA 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.NULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
10EUCTR2015-003148-38-BE
(EUCTR)
06/06/201619/04/2016Effect of nintedanib on biomarkersA 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. VNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
11EUCTR2015-003148-38-GB
(EUCTR)
06/06/201618/04/2016Effect of nintedanib on biomarkersA 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 LimitedNULLNot 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): yesUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
12EUCTR2015-003148-38-HU
(EUCTR)
27/05/201612/04/2016Effect of nintedanib on biomarkersA 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 KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
13EUCTR2015-003148-38-CZ
(EUCTR)
26/05/201611/04/2016Effect of nintedanib on biomarkersA 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 KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of;United States
14EUCTR2015-003148-38-FR
(EUCTR)
24/05/201604/05/2016Effect of nintedanib on biomarkersA 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 FranceNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
15EUCTR2015-003148-38-FI
(EUCTR)
17/05/201612/04/2016Effect of nintedanib on biomarkersA 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 KyNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
16EUCTR2015-000640-42-DE
(EUCTR)
01/12/201503/09/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA 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.KGNULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Netherlands;Germany;Italy
17EUCTR2015-000640-42-NL
(EUCTR)
13/10/201518/08/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA 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 bvNULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Germany;Netherlands;Italy
18EUCTR2015-000640-42-FR
(EUCTR)
26/08/201505/08/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA 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 FranceNULLNot RecruitingFemale: yes
Male: yes
135Phase 4United States;France;Canada;Netherlands;Germany;Italy