Osilodrostat 20mg ( DrugBank: Osilodrostat )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
75クッシング病10

75. クッシング病


臨床試験数 : 205 薬物数 : 176 - (DrugBank : 45) / 標的遺伝子数 : 61 - 標的パスウェイ数 : 127
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-004092-23-PT
(EUCTR)
14/10/201603/08/2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
69Phase 3United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Belgium;Brazil;Poland;China
2EUCTR2014-004092-23-PL
(EUCTR)
08/09/201625/07/2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
69Phase 3United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Poland;Belgium;Brazil;Denmark;China
3EUCTR2014-004092-23-BE
(EUCTR)
09/08/201618/05/2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
69Phase 3United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Belgium;Brazil;Poland;China
4EUCTR2014-004092-23-GR
(EUCTR)
05/07/201611/05/2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 Cushing's disease
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
69Phase 3Portugal;United States;Greece;Thailand;Spain;Poland;Brazil;Belgium;Turkey;Denmark;Russian Federation;Switzerland
5EUCTR2014-004092-23-ES
(EUCTR)
29/04/201618/03/2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing?s disease - LINC-4 Cushing's disease
MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
69Phase 3Portugal;United States;Greece;Thailand;Poland;Brazil;Belgium;Spain;Turkey;Denmark;Russian Federation;Switzerland
6EUCTR2013-004766-34-NL
(EUCTR)
04/02/201521/08/2014Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's diseaseA Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04]Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Thailand;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of
7EUCTR2013-004766-34-FR
(EUCTR)
28/11/201408/02/2019Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's diseaseA Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04]Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 20mg
Product Code: LCI699
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of
8EUCTR2013-004766-34-GB
(EUCTR)
20/11/201422/07/2014Safety and efficacy of LCI699 for the treatment of patients with Cushing's diseaseA Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04]Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
132Phase 3Colombia;Argentina;Russian Federation;United States;Japan;United Kingdom;Thailand;India;Spain;Canada;Austria;Netherlands;Turkey;China;Korea, Republic of;Italy;Australia;Bulgaria;France;Germany
9EUCTR2013-004766-34-DE
(EUCTR)
06/10/201429/07/2014Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's diseaseA Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04]Product Name: osilodrostat 1mg
Product Code: LCI699, 1 mg
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 5mg
Product Code: LCI699, 5 mg
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 10mg
Product Code: LCI699, 10 mg
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 20mg
Product Code: LCI699, 20 mg
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Thailand;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of
10EUCTR2013-004766-34-AT
(EUCTR)
05/08/201431/07/2014Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's diseaseA Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 20mg
Product Code: LCI699
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of