OSILODROSTAT ( 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32

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
1NCT05633953
(ClinicalTrials.gov)
December 202216/11/2022Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's SyndromeA Retrospective Observational Study to Evaluate the Safety and Effectiveness of Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome (LINC7)Cushing's SyndromeDrug: OsilodrostatRECORDATI GROUPNULLNot yet recruiting18 YearsN/AAll50NULL
2NCT05382156
(ClinicalTrials.gov)
June 20223/5/2022Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's SyndromeA Non-interventional Study to Assess the Long-term Safety and Efficacy of Osilodrostat in Patients With Endogenous Cushing's SyndromeEndogenous Cushing's SyndromeDrug: OsilodrostatRECORDATI GROUPNULLNot yet recruiting18 YearsN/AAll100NULL
3NCT03708900
(ClinicalTrials.gov)
April 28, 20218/10/2018Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's DiseaseA Phase II, Multicenter, Open-label, Non-comparative Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Osilodrostat in Children and Adolescent Patients With Cushing's DiseaseCushing's DiseaseDrug: LCI699RECORDATI GROUPNULLRecruiting6 Years17 YearsAll12Phase 2Belgium;Bulgaria;Italy;Slovenia;United Kingdom
4EUCTR2018-001522-25-IT
(EUCTR)
20/01/202028/04/2020A study of osilodrostat in children and adolescents with Cushing's diseaseA phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent 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
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy
5EUCTR2017-002840-34-NL
(EUCTR)
14/11/201931/07/2019Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;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
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Portugal;United States;Spain;Costa Rica;Thailand;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Netherlands;China;Japan;Korea, Republic of
6EUCTR2018-001522-25-ES
(EUCTR)
02/10/201926/07/2019A study of osilodrostat in children and adolescents with Cushing's diseaseA phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent 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
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
12Phase 2United States;Slovenia;Belgium;Spain;Bulgaria;Italy;United Kingdom
7EUCTR2017-002840-34-FR
(EUCTR)
08/07/201914/06/2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders ;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
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
8EUCTR2018-001522-25-BG
(EUCTR)
04/07/201926/03/2019A study of osilodrostat in children and adolescents with Cushing's diseaseA phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent 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
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy
9EUCTR2017-002840-34-BG
(EUCTR)
18/06/201907/09/2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;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
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Portugal;Greece;Thailand;Costa Rica;Spain;Russian Federation;Colombia;Italy;Switzerland;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
10EUCTR2018-001522-25-BE
(EUCTR)
05/06/201930/04/2019A study of osilodrostat in children and adolescents with Cushing's diseaseA phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent 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
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy
11EUCTR2018-001522-25-SI
(EUCTR)
10/05/201916/10/2018A study of osilodrostat in children and adolescents with Cushing's diseaseA phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent 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
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy
12EUCTR2018-001522-25-GB
(EUCTR)
19/03/201927/09/2018A study of osilodrostat in children and adolescents with Cushing's diseaseA phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent 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
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: OSILODROSTAT
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;Slovenia;Spain;Belgium;Bulgaria;Italy;United Kingdom
13EUCTR2017-002840-34-BE
(EUCTR)
07/02/201916/11/2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders ;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
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
14EUCTR2017-002840-34-ES
(EUCTR)
31/10/201811/07/2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;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
Novartis Farmacéutica, S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
15NCT03606408
(ClinicalTrials.gov)
October 5, 201820/7/2018Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety in Patients With Endogenous Cushing's Syndrome Who Have Completed a Prior Novartis-sponsored Osilodrostat (LCI699) Study and Are Judged by the Investigator to Benefit From Continued Treatment With OsilodrostatCushing's SyndromeDrug: osilodrostatRECORDATI GROUPNULLActive, not recruiting18 Years75 YearsAll180Phase 2United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;China;Costa Rica;France;Germany;India;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Thailand;Turkey
16EUCTR2017-002840-34-IT
(EUCTR)
01/10/201817/06/2021Roll-over study to assess long-term safety in patients with endogenous Cushing's syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat - NA Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;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
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Portugal;Greece;Thailand;Costa Rica;Spain;Russian Federation;Colombia;Italy;Switzerland;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany
17EUCTR2017-002840-34-AT
(EUCTR)
03/08/201822/05/2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;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
Recordati AGNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Portugal;Thailand;Spain;Costa Rica;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of
18EUCTR2017-002840-34-DE
(EUCTR)
13/07/201829/05/2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;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
Recordati AGNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Portugal;United States;Spain;Costa Rica;Thailand;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of
19EUCTR2014-004092-23-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
20NCT02697734
(ClinicalTrials.gov)
October 3, 201627/2/2016Efficacy and Safety Evaluation of Osilodrostat in 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 DiseaseCushing's DiseaseDrug: osilodrostat;Drug: osilodrostat PlaceboNovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll73Phase 3United States;Belgium;Brazil;Canada;China;Costa Rica;Greece;Poland;Portugal;Russian Federation;Spain;Switzerland;Thailand;Turkey
21EUCTR2014-004092-23-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
22EUCTR2014-004092-23-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
23EUCTR2014-004092-23-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
24EUCTR2014-004092-23-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
25NCT02468193
(ClinicalTrials.gov)
September 24, 20158/6/2015Study of Efficacy and Safety of Osilodrostat in Cushing's SyndromeA Phase II, Open-label, Dose Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of Osilodrostat in Patients With All Types of Endogenous Cushing's Syndrome Except Cushing's DiseaseCushing's Syndrome;Ectopic Corticotropin Syndrome;Adrenal Adenoma;Adrenal Carcinoma;AIMAH;PPNADDrug: OsilodrostatNovartis PharmaceuticalsNULLCompleted18 Years85 YearsAll9Phase 2Japan
26EUCTR2013-004766-34-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
27EUCTR2013-004766-34-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
28EUCTR2013-004766-34-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
29NCT02180217
(ClinicalTrials.gov)
October 6, 201417/6/2014Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's DiseasePhase 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 DiseaseCushings DiseaseDrug: osilodrostat;Drug: LCI699 matching placeboNovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll137Phase 3United States;Argentina;Austria;Bulgaria;Canada;China;Colombia;France;Germany;India;Italy;Japan;Korea, Republic of;Netherlands;Russian Federation;Spain;Thailand;Turkey;United Kingdom;Australia
30EUCTR2013-004766-34-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
31EUCTR2013-004766-34-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
32EUCTR2017-002840-34-PL
(EUCTR)
05/03/2020Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;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
Recordati AGNULLNAFemale: yes
Male: yes
200Phase 2United States;Portugal;Thailand;Spain;Costa Rica;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of