75. クッシング病
[臨床試験数:191,薬物数:172(DrugBank:48),標的遺伝子数:61,標的パスウェイ数:121

Searched query = "Cushing disease", "Cushing"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
109 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03708900
(ClinicalTrials.gov)
October 30, 20208/10/2018Pharmacokinetic (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: LCI699Novartis PharmaceuticalsNULLRecruiting6 Years18 YearsAll12Phase 2Belgium;Bulgaria;Italy;Slovenia;United Kingdom
2EUCTR2018-001616-30-BG
(EUCTR)
27/03/202024/02/2020Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome Endogenous Cushing Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3United States;Hungary;Canada;Spain;Poland;Romania;Austria;Israel;Bulgaria;Netherlands;Germany;Italy
3EUCTR2018-001616-30-ES
(EUCTR)
14/02/202010/01/2020Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome Endogenous Cushing Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Physiological processes [G07]
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Canada;Poland;Spain;Romania;Austria;Israel;Bulgaria;Netherlands;Germany;Italy
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 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
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
7EUCTR2017-004647-20-NL
(EUCTR)
29/08/201923/11/2018A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeAn Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;United States;Hungary;Greece;Poland;Spain;Romania;Israel;Bulgaria;Netherlands;Italy
8EUCTR2017-002840-34-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]
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
9EUCTR2018-001522-25-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
10EUCTR2017-002840-34-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;Costa Rica;Spain;Thailand;Russian Federation;Colombia;Italy;Switzerland;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-001522-25-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
12EUCTR2018-001522-25-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
13EUCTR2017-004647-20-GR
(EUCTR)
21/03/201919/02/2019A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeAn Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
14EUCTR2018-001522-25-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
15EUCTR2017-004647-20-BG
(EUCTR)
11/02/201924/10/2018A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeAn Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;United States;Hungary;Greece;Poland;Spain;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-002840-34-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]
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
17EUCTR2017-004647-20-ES
(EUCTR)
17/01/201925/10/2018A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeAn Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Cortendo ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;France;Hungary;Poland;Romania;Denmark;Bulgaria;Netherlands
18EUCTR2017-004647-20-IT
(EUCTR)
11/01/201915/11/2018A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeAn Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Cortendo ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;France;Hungary;Poland;Romania;Denmark;Bulgaria;Netherlands
19NCT03621280
(ClinicalTrials.gov)
January 7, 201918/5/2018Open-label Treatment in Cushing's SyndromeAn Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's SyndromeCushing Syndrome;Cushing DiseaseDrug: LevoketoconazoleCortendo ABNULLRecruiting18 YearsN/AAll60Phase 3United States;Bulgaria;France;Greece;Hungary;Israel;Italy;Netherlands;Poland;Romania;Spain;Denmark;Turkey
20EUCTR2017-004647-20-HU
(EUCTR)
13/11/201826/09/2018A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeAn Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3Hungary;Poland;Romania;United States;Greece;Spain;Turkey;Israel;Italy;France;Denmark;Bulgaria;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2017-002840-34-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
22NCT03606408
(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: osilodrostatNovartis PharmaceuticalsNULLRecruiting18 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
23EUCTR2017-002840-34-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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
24EUCTR2017-002840-34-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 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
25EUCTR2018-001616-30-HU
(EUCTR)
09/07/201814/05/2018Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome Endogenous Cushing Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
Corcept Therapeutics IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Hungary;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2017-001219-35-NL
(EUCTR)
24/05/201829/11/2017A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Cortendo ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
54 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Hungary;Greece;Poland;Spain;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
27EUCTR2017-001219-35-FR
(EUCTR)
23/05/201824/10/2017A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLNot RecruitingFemale: yes
Male: yes
35Phase 3United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands
28EUCTR2017-001219-35-GR
(EUCTR)
08/05/201804/04/2018A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLNot RecruitingFemale: yes
Male: yes
54Phase 3United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
29NCT03604198
(ClinicalTrials.gov)
May 7, 20181/5/2018Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing SyndromeAn Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing SyndromeCushing SyndromeDrug: relacorilantCorcept TherapeuticsNULLEnrolling by invitationN/AN/AAll75Phase 2United States;Austria;Bulgaria;Italy;Spain
30EUCTR2017-001219-35-DK
(EUCTR)
14/02/201819/12/2017A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLNot RecruitingFemale: yes
Male: yes
35Phase 3United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2017-001219-35-BG
(EUCTR)
23/01/201830/10/2017A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLNot RecruitingFemale: yes
Male: yes
54Phase 3United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
32EUCTR2017-001219-35-ES
(EUCTR)
22/01/201817/10/2017A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands
33EUCTR2017-001219-35-PL
(EUCTR)
16/01/201828/11/2017A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLNot RecruitingFemale: yes
Male: yes
54Phase 3United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
34EUCTR2017-001219-35-HU
(EUCTR)
12/01/201816/11/2017A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s SyndromeA Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing´s syndrome (CS)
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLNot RecruitingFemale: yes
Male: yes
35Phase 3United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy
35EUCTR2013-000267-84-BG
(EUCTR)
12/12/201718/09/2017Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing's diseaseAcromegaly Carcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanoma Metastatic Merkel cell carcinoma;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: Signifor
Product Name: pasireotide 20mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 40mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 60mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 4Portugal;United States;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT03277690
(ClinicalTrials.gov)
September 26, 20177/9/2017A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open Label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing's SyndromeEndogenous Cushing's SyndromeDrug: Levoketoconazole;Drug: PlaceboCortendo ABNULLCompleted18 YearsN/AAll44Phase 3United States;Bulgaria;Denmark;France;Greece;Hungary;Israel;Italy;Netherlands;Poland;Romania;Spain
37ChiCTR-OPC-17011664
2017-08-012017-06-14A single center clinical study of EGFR/HER2 targeted inhibitor Lapatinib in the treatment of refractory Cushing's diseaseA single center clinical study of EGFR/HER2 targeted inhibitor Lapatinib in the treatment of refractory Cushing's disease Pituitary ACTH-secreting adenomaTreatment group:lapatinib;Peking Union Medical College HospitalNULLPending1875BothTreatment group:30;China
38EUCTR2013-000267-84-PT
(EUCTR)
24/04/201722/02/2017Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing's diseaseAcromegaly Carcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanoma Metastatic Merkel cell carcinoma
MedDRA version: 20.0;Level: PT;Classification code 10000599;Term: Acromegaly;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Level: LLT;Classification code 10007271;Term: Carcinoid tumor;System Organ Class: 100000004864
MedDRA version: 20.0;Classification code 10062476;Term: Neuroendocrine tumor;Classification code 10011651;Term: Cushing's disease;Classification code 10027481;Term: Metastatic melanoma;System Organ Class: 100000004864
MedDRA version: 20.1;Classification code 10013810;Term: Dumping syndrome;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10064025;Term: Merkel cell carcinoma;System Organ Class: 100000004864;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide 20mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 40mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 60mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
220Phase 4United States;Portugal;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of
39EUCTR2014-000162-22-PL
(EUCTR)
27/07/201621/04/2016Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment periodProspective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT Treatment of 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]
Laboratoire HRA PharmaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesHungary;Belgium;Spain;Poland;Romania;Turkey;Germany;Italy
40EUCTR2013-002133-37-HU
(EUCTR)
05/04/201624/09/2015A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's DiseaseAn Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing's syndrome (CS) or Cushing's disease
MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Cortendo ABNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2013-002133-37-CZ
(EUCTR)
22/02/201627/07/2015A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's DiseaseAn Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing's syndrome (CS) or Cushing's disease
MedDRA version: 19.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Cortendo ABNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden
42EUCTR2013-000267-84-PL
(EUCTR)
05/02/201616/12/2015Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment - Roll over protocol with pasireotide Cushing's diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAF
MedDRA version: 21.0;Level: LLT;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864
MedDRA version: 20.0;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 20.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Not possible to specify
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Portugal;United States;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of
43EUCTR2013-002133-37-BG
(EUCTR)
15/10/201507/07/2015A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's DiseaseAn Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing's syndrome (CS) or Cushing's disease
MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Cortendo ABNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden
44EUCTR2014-000162-22-HU
(EUCTR)
06/10/201508/07/2015Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment periodProspective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT Treatment of Cushing’s syndrome
MedDRA version: 18.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: metyrapone
INN or Proposed INN: METYRAPONE
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 4Hungary;Spain;Poland;Belgium;Germany;Italy
45NCT02468193
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2013-002133-37-DE
(EUCTR)
23/09/201512/06/2014A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's DiseaseAn Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing's syndrome (CS) or Cushing's disease
MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: COR-003
Product Code: COR-003
INN or Proposed INN: not available
Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole
Cortendo ABNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Sweden
47EUCTR2013-002133-37-DK
(EUCTR)
31/07/201520/03/2014A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's DiseaseAn Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing's syndrome (CS) or Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: COR-003
Product Code: COR-003
INN or Proposed INN: Not available
Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole
Cortendo ABNULLNot RecruitingFemale: yes
Male: yes
90Phase 3United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Sweden
48EUCTR2012-002916-16-PL
(EUCTR)
29/06/201516/03/2015Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegalyA multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. Cushing's disease and acromegaly
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: pasireotide pamoate
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE PAMOATE
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE PAMOATE
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
133Phase 4United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China
49EUCTR2012-002916-16-BE
(EUCTR)
04/05/201531/03/2015Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegalyA multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. Cushing's disease and acromegaly
MedDRA version: 17.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 17.1;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
132Phase 4United States;Spain;Thailand;Turkey;Russian Federation;India;Poland;Belgium;Brazil;Romania;Denmark;Peru;Bulgaria;Germany;Netherlands;China
50EUCTR2014-000162-22-DE
(EUCTR)
04/05/201530/10/2014Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment periodProspective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT Treatment of 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]
Trade Name: Metopirone 250 mg capsules
Product Name: metyrapone
INN or Proposed INN: METYRAPONE
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 4Hungary;Poland;Romania;Germany;Italy;Spain;Belgium;Turkey
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT02297945
(ClinicalTrials.gov)
April 201519/11/2014Effects of Metyrapone in Patients With Endogenous Cushing's SyndromeProspective, Single Arm, Open-label, Multicenter, International Study to Assess the Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome During a 12-week Treatment Period Followed by an Extension Period of 24 WeeksCushing's SyndromeDrug: metyraponeHRA PharmaNULLCompleted18 YearsN/AAll50Phase 3Belgium;Germany;Hungary;Italy;Poland;Romania;Spain;Turkey
52EUCTR2014-000162-22-IT
(EUCTR)
19/03/201525/11/2014Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment periodProspective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT Treatment of Cushing’s syndrome
MedDRA version: 17.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Metopirone 250 mg capsules/Cormeto
Product Name: metyrapone
INN or Proposed INN: METYRAPONE
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 4United States;Hungary;Spain;Poland;Belgium;Germany;Switzerland;Italy;Sweden
53EUCTR2013-000267-84-ES
(EUCTR)
11/03/201503/03/2015Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment - Roll over protocol with pasireotide Cushing's disease Acromegaly Neuroendocrine tumors Pituitary tumors EctopicACTH secreting (EAS) tumors Dumping Syndrome Prostate cancer Melanomanegative for bRAF;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Taiwan;Greece;Spain;Thailand;Russian Federation;Israel;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;China;Korea, Republic of
54EUCTR2014-000162-22-BE
(EUCTR)
11/03/201504/12/2014Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment periodProspective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT Treatment of Cushing’s syndrome
MedDRA version: 17.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Metopirone 250 mg capsules
Product Name: metyrapone
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 4United States;Hungary;Spain;Poland;Belgium;Germany;Switzerland;Italy;Sweden
55EUCTR2014-000162-22-ES
(EUCTR)
23/02/201516/01/2015Study to assess the effects of metyrapone in patients with Cushing?s syndrome during a 12-week treatment periodProspective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing?s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT Treatment of Cushing?s syndrome
MedDRA version: 17.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Metopirone 250 mg capsules
Product Name: metyrapone
INN or Proposed INN: METYRAPONE
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Hungary;Poland;Belgium;Spain;Germany;Italy;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2013-004766-34-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
57EUCTR2013-004766-34-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]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
58EUCTR2013-004766-34-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 3United States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of
59EUCTR2013-002133-37-IT
(EUCTR)
17/11/201404/09/2014A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s SyndromeAn Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing's syndrome (CS)
MedDRA version: 17.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Cortendo ABNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Bulgaria;Georgia;Germany;Netherlands;Sweden
60EUCTR2013-002133-37-GB
(EUCTR)
17/11/201418/06/2013A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's DiseaseAn Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing's syndrome (CS) or Cushing's disease
MedDRA version: 19.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Cortendo ABNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT02180217
(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
62EUCTR2013-004766-34-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
63EUCTR2013-002133-37-SE
(EUCTR)
18/09/201412/03/2014A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's DiseaseAn Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing's syndrome (CS) or Cushing's disease
MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Cortendo ABNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden
64EUCTR2012-002916-16-DE
(EUCTR)
19/08/201417/03/2014 Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. Cushing's disease and acromegaly
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
133 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China
65EUCTR2013-004766-34-ES
(EUCTR)
13/08/201411/08/2014Safety 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 Code: LCI699
INN or Proposed INN: LCI699
Other descriptive name: LCI699
Product Code: LCI699
INN or Proposed INN: LCI699
Other descriptive name: LCI699
Product Code: LCI699
INN or Proposed INN: LCI699
Other descriptive name: LCI699
Product Code: LCI699
INN or Proposed INN: LCI699
Other descriptive name: LCI699
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2013-004766-34-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]
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
67EUCTR2013-004766-34-IT
(EUCTR)
01/08/201413/06/2014Safety 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: NA
Product Code: LCI699
INN or Proposed INN: NA
Other descriptive name: LCI699
Product Name: NA
Product Code: LCI699
INN or Proposed INN: NA
Other descriptive name: LCI699
Product Name: NA
Product Code: LCI699
INN or Proposed INN: NA
Other descriptive name: LCI699
Product Name: NA
Product Code: LCI699
INN or Proposed INN: NA
Other descriptive name: LCI699
NOVARTIS FARMA S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United States;Taiwan;Slovakia;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of
68NCT01838551
(ClinicalTrials.gov)
August 201419/4/2013Treatment for Endogenous Cushing's SyndromeAn Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's SyndromeEndogenous Cushing's SyndromeDrug: COR-003Cortendo ABNULLCompleted18 YearsN/AAll90Phase 3United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Serbia;Spain;Turkey;Czech Republic;Georgia;Hungary;Sweden;Switzerland;United Kingdom
69EUCTR2013-002133-37-NL
(EUCTR)
10/07/201411/03/2014A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's DiseaseAn Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing's syndrome (CS) or Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Cortendo ABNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Germany;Netherlands;Sweden
70EUCTR2013-002133-37-BE
(EUCTR)
09/07/201411/02/2014A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's DiseaseAn Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing's syndrome (CS) or Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: COR-003
Product Code: COR-003
INN or Proposed INN: Not available
Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole
Cortendo ABNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2012-002916-16-DK
(EUCTR)
01/07/201409/04/2014Study of management of pasireotide-induced hyperglycemiain adult patients with Cushing’s disease or acromegalyA multi-center, randomized, open-label, Phase IV study toinvestigate the management of pasireotide-inducedhyperglycemia with incretin based therapy or insulin inadult patients with Cushing’s disease or acromegaly. Cushing's disease and acromegaly
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: SOM230B
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Other descriptive name: PASIREOTIDE PAMOATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Other descriptive name: PASIREOTIDE PAMOATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
133Phase 4United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China
72EUCTR2013-002133-37-ES
(EUCTR)
26/05/201412/11/2013A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have a medical condition in which they produce too much of a steriod hormone known as cortisol An Open Label Study to Assess the Safety and Efficiacy of COR-003 (2S,4R- Ketoconazole) in the Treatment of Endogenous Cushing's Syndrome (CS) Estudio abierto para evaluar la seguridad y la eficacia del producto COR-003 (2S, 4R-ketoconazol) en el tratamiento del síndrome de Cushing endógeno (SC) Endogenous Cushing's syndrome (CS)
MedDRA version: 16.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Cortendo ABNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Austria;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Denmark;Bulgaria;Netherlands;Germany;China;Sweden
73NCT02060383
(ClinicalTrials.gov)
May 23, 201410/2/2014Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or AcromegalyA Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or AcromegalyCushing's Disease;AcromegalyDrug: Pasireotide s.c.;Drug: Sitagliptin;Drug: Liraglutide;Drug: Insulin;Drug: Pasireotide LAR;Drug: MetforminNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll249Phase 4United States;Belgium;Brazil;China;Denmark;Germany;India;Peru;Poland;Russian Federation;Thailand;Turkey
74EUCTR2013-002063-26-IT
(EUCTR)
08/09/201323/07/2013A trial with Metyrapone in Cushing's syndromeA prospective open-label Phase 2 study of METYRAPONE as a preoperative treatment in patients with ACTH-independent Cushing’s syndrome due to adrenal adenoma. - METYX01 Cushing's syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: Matyrapone
Product Name: Metyrapone
Product Code: Metyrapone
S.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi OrbassanoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 2Italy
75EUCTR2013-000267-84-FR
(EUCTR)
07/08/201323/09/2015An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatmentAn open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing’s diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAFTrade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Greece;Spain;Thailand;Russian Federation;Israel;Italy;France;Mexico;Canada;Belgium;Brazil;Australia;Germany;Norway;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT01925092
(ClinicalTrials.gov)
August 20138/8/2013Mifepristone in Children With Refractory Cushing's DiseaseAn Open-label Study of the Safety, Pharmacokinetics and Pharmacodynamics of Mifepristone in Children With Refractory Cushing's DiseaseCushing's DiseaseDrug: mifepristoneCorcept TherapeuticsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Withdrawn6 Years17 YearsBoth0Phase 3United States
77NCT01794793
(ClinicalTrials.gov)
June 10, 201315/2/2013Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored StudiesAn Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide TreatmentCushing's Disease;Acromegaly;Neuroendocrine Tumors;Pituitary Tumors;Ectopic ACTH Secreting (EAS) Tumors;Dumping Syndrome;Prostate Cancer;Melanoma Negative for bRAF;Melanoma Negative for nRASDrug: Pasireotide;Drug: CabergolineRECORDATI GROUPNULLActive, not recruiting18 YearsN/AAll413Phase 4United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Taiwan;Thailand;Turkey;China
78EUCTR2013-000267-84-IT
(EUCTR)
07/06/201308/04/2013Protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatmentAn open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing’s diseaseNeuroendocrine tumors
MedDRA version: 14.1;Level: LLT;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864
MedDRA version: 14.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
NOVARTIS FARMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Mexico;Canada;Belgium;Brazil;Thailand;Australia;Israel;Russian Federation;China;Italy
79EUCTR2013-000267-84-BE
(EUCTR)
05/06/201322/04/2013Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing's diseaseAcromegalyCarcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanomaMetastatic Merkel cell carcinoma;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4Portugal;United States;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;China
80EUCTR2010-024165-44-NL
(EUCTR)
24/04/201222/12/2011Study of pasireotide s.c. in patients with Cushing's diseaseAn open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape Cushing’s disease
MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: SOM230
INN or Proposed INN: pasireotide
INN or Proposed INN: pasireotide
INN or Proposed INN: pasireotide
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Hungary;Germany;Czech Republic;Egypt;Netherlands;Argentina;Korea, Republic of;Romania;Thailand;Spain;Greece;Brazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2009-011128-70-NL
(EUCTR)
18/11/201110/08/2011A phase 3 studie to evaluate if pasireotide is safe and works in patients with Cushing’s diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease Cushing's disease
MedDRA version: 16.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
148Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Netherlands;Germany;China;Japan
82NCT01374906
(ClinicalTrials.gov)
November 4, 201114/6/2011Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's DiseaseA Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's DiseaseCushing's DiseaseDrug: pasireotide LAR;Drug: SOM230 LAR 30 mg;Drug: SOM230 LAR 10 mgNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll150Phase 3United States;Argentina;Belgium;Brazil;Canada;China;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Russian Federation;Spain;Thailand;Turkey;United Kingdom
83EUCTR2009-011128-70-BE
(EUCTR)
25/10/201107/09/2011A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease Cushing's disease
MedDRA version: 19.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;China;Japan
84EUCTR2009-011128-70-PL
(EUCTR)
12/10/201114/09/2011phase III study to evaluate safety and efficacy of pasireotide LAR in patients with Cushing's diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease - Cushing's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Belgium;Poland;Brazil;Peru;Germany;China;Japan
85EUCTR2009-011128-70-IT
(EUCTR)
10/10/201128/02/2012A phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing's diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing's disease Cushing's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;China;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2009-011128-70-DE
(EUCTR)
04/10/201122/07/2011phase III study to evaluate safety and efficacy of pasireotide LAR in patients with Cushing's diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease Cushing's disease
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Peru;Germany;China;Japan
87EUCTR2009-011128-70-ES
(EUCTR)
22/09/201118/07/2011Estudio de fase III, de muchos centros, aleatorizado a dos dosis distintas de medicación sin que el médico ni el paciente sepa en cual está, para evaluar la eficacia y seguridad de pasireotida LAR (de larga duración) en pacientes con enfermedad de Cushing.Estudio de fase III, multicéntrico, aleatorizado y doble ciego, para evaluar la eficacia y seguridad de pasireotida LAR en pacientes con enfermedad de Cushing Enfermedad de Cushing
MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: Pasireotide
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: Pasireotide
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;Spain;Thailand;Turkey;Russian Federation;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Peru;Germany;China;Japan
88EUCTR2010-024165-44-CZ
(EUCTR)
02/09/201118/07/2011safety and efficacy of pasireotide s.c. in patients with Cushing's disease An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape Cushing’s disease
MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Signifor
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
INN or Proposed INN: PASIREOTIDE DIASPARTATE
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United States;Czech Republic;Greece;Brazil;Thailand;Spain;Romania;Russian Federation;Netherlands;Germany;Korea, Republic of
89EUCTR2009-011128-70-GB
(EUCTR)
24/08/201115/07/2011A randomized, double-blind, multicentre, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s diseaseA randomized, double-blind, multicentre, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease Cushing's disease
MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
162 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;Netherlands;China;Japan
90NCT01582061
(ClinicalTrials.gov)
August 16, 201112/4/2012An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape).Cushing's DiseaseDrug: Pasireotide sub-cutaneousNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll104Phase 3United States;Brazil;Czechia;Germany;Greece;Korea, Republic of;Lebanon;Romania;Russian Federation;Spain;Thailand;Czech Republic;Egypt;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2010-024165-44-GR
(EUCTR)
09/08/201122/06/2011An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - SeascapeAn open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape Cushing’s disease
MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders
Product Name: N/A
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: -
INN or Proposed INN: pasireotide
INN or Proposed INN: pasireotide
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
300Czech Republic;Greece;Spain;Netherlands;Germany
92EUCTR2010-024165-44-DE
(EUCTR)
05/08/201112/05/2011An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape)An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape Cushing’s disease
MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Signifor
Product Name: Signifor
Product Code: SOM230 300µg
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: Signifor
Product Code: SOM230 600µg
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: Signifor
Product Code: SOM230 900µg
INN or Proposed INN: pasireotide
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Czech Republic;Greece;Spain;Netherlands;Germany
93EUCTR2010-022403-22-IT
(EUCTR)
04/07/201120/09/2011Open-label, multicenter study to assess the safety/tolerability and efficacy of 10-weeks treatment of LCI699 in patients with Cushing’s diseaseA proof-of concept, open-label, forced titration, multicenter study to assess the safety/tolerability and efficacy of 10-weeks treatment of LCI699 in patients with Cushing’s disease Cushing's disease
MedDRA version: 14.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: LCI699
Product Code: LCI699
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
15Phase 2United States;Italy
94NCT01331239
(ClinicalTrials.gov)
March 23, 20116/4/2011Safety and Efficacy of LCI699 in Cushing's Disease Patients.A Proof of Concept, Open-label, Forced Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of 10-weeks Treatment of LCI699 Followed by a 12 - Week Treatment Period of LCI699 in Patients With Cushing's DiseaseCushing's DiseaseDrug: LCI699Novartis PharmaceuticalsNULLCompleted18 Years75 YearsAll33Phase 2United States;France;Italy;Japan
95NCT00936741
(ClinicalTrials.gov)
July 20099/7/2009An Extension Study of CORLUX in the Treatment of Endogenous Cushing's SyndromeAn Open Label Extension Study of the Efficacy and Safety of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's SyndromeCushing's SyndromeDrug: mifepristoneCorcept TherapeuticsNULLCompleted18 YearsN/AAll30Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2008-002280-14-FR
(EUCTR)
18/07/200806/06/2008Comparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trialComparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trial The Active substance of Osteopor is Ossein Hydroxyapatite.Treatment of processes characterized by decalcification: osteoporosis, Cushing syndrome, thyrotoxicosis.
MedDRA version: 9.1;Level: LLT;Classification code 10006956;Term: Calcium deficiency
Trade Name: OSTEOPOR
Product Name: OSTEOPOR
Product Code: L0006CP03A
INN or Proposed INN: ossein hydroxyapatite
Trade Name: OROCAL
Product Name: OROCAL
INN or Proposed INN: calcium carbonate
Pierre Fabre MédicamentNULLNot RecruitingFemale: yes
Male: no
60Phase 3France
97NCT00569582
(ClinicalTrials.gov)
December 20075/12/2007A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's SyndromeAn Open-label Study of the Efficacy and Safety of CORLUX (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's SyndromeCushing's SyndromeDrug: mifepristoneCorcept TherapeuticsNULLCompleted18 YearsN/AAll50Phase 3United States
98NCT00422201
(ClinicalTrials.gov)
May 15, 200712/1/2007Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) SecretionProspective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) SecretionCushing's SyndromeDrug: MifepristoneHRA PharmaNULLTerminated18 Years85 YearsAll18Phase 2United States;France;Germany;Italy;Netherlands;United Kingdom
99EUCTR2006-004080-55-NL
(EUCTR)
26/04/200719/01/2007Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's DiseaseStepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's Disease The medical condition to be investigated is Cushing's disease which is caused by an ACTH producing pituitary adenoma
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: SOM230
Product Code: SOM230B
INN or Proposed INN: pasireotide
Trade Name: Dostinex
Product Name: Dostinex
INN or Proposed INN: CABERGOLINE
Trade Name: Nizoral
Product Name: Ketoconazole
INN or Proposed INN: KETOCONAZOLE
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
100EUCTR2006-004679-36-DE
(EUCTR)
05/04/200709/10/2006Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EASProspective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion.
MedDRA version: 14.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 14.0;Classification code 10014146;Term: Ectopic ACTH syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Code: HRA052015
INN or Proposed INN: mifepristone
Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
35France;United States;Netherlands;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT00612066
(ClinicalTrials.gov)
April 20078/2/2008Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease)An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's DiseaseCushing's DiseaseDrug: rosiglitazone maleateJonsson Comprehensive Cancer CenterNational Institutes of Health (NIH)Terminated18 Years65 YearsAll2Phase 2United States
102EUCTR2006-004679-36-NL
(EUCTR)
22/03/200731/01/2007Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EASProspective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion.
MedDRA version: 8.1;Level: LLT;Classification code 10014155;Term: Ectopic corticotrophin syndrome
Product Code: HRA052015
INN or Proposed INN: mifepristone
Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
22Germany;Netherlands;France;Italy
103EUCTR2006-004679-36-IT
(EUCTR)
15/01/200730/01/2007Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing s syndrome caused by ectopic Adrenal Corticotrophin Hormone ACTH secretion - HRA052015 in EASProspective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing s syndrome caused by ectopic Adrenal Corticotrophin Hormone ACTH secretion - HRA052015 in EAS Cushing s Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone ACTH Secretion
MedDRA version: 9.1;Level: LLT;Classification code 10014146;Term: Ectopic ACTH syndrome
Product Name: Mifepristone
Product Code: HRA052015
LABORATOIRE HRA PHARMANULLNot RecruitingFemale: yes
Male: yes
22Germany;Netherlands;France;Italy
104EUCTR2006-004679-36-FR
(EUCTR)
13/12/200629/09/2006Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EASProspective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion.
MedDRA version: 8.1;Level: LLT;Classification code 10014155;Term: Ectopic corticotrophin syndrome
Product Code: HRA052015
INN or Proposed INN: mifepristone
Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
22France;Netherlands;Germany;Italy
105NCT01959711
(ClinicalTrials.gov)
January 20066/10/2013Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic AdrenalectomyRandomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Transperitoneal Laparoscopic Adrenalectomy With a Five-year Follow-upAdrenal Tumor;Pheochromocytoma;Conn's Syndrome;Cushing's SyndromeProcedure: Posterior RA;Procedure: Lateral transperitoneal LAJagiellonian UniversityNULLCompleted18 Years80 YearsBoth65Phase 4Poland
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
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agemin
Inclusion_
agemax
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PhaseCountries
106EUCTR2004-002407-32-GB
(EUCTR)
13/01/200527/06/2005Extension to a multicenter, open label study to assess the safety and efficacy of 600 micrograms SOM230, administered subcutaneously, b.i.d. in patients with Cushing's diseaseExtension to a multicenter, open label study to assess the safety and efficacy of 600 micrograms SOM230, administered subcutaneously, b.i.d. in patients with Cushing's disease Cushing’s disease is an endocrine disease that is caused by an Adrenocorticotropic hormone (ACTH) secreting pituitary adenoma, which is a benign tumor of the pituitary gland. This elevated ACTH stimulates the adrenal glands to produce excess cortisol and subsequent development of the clinical signs and symptoms which include: upper body obesity, severe fatigue and muscle weakness, high blood pressure, backache, elevated blood sugar, and menstrual disorders in womenProduct Code: SOM230B
INN or Proposed INN: Pasireotide
Other descriptive name: Cyclo(diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe)
Novartis Pharmaceuticals UK LtdNULLNot RecruitingFemale: yes
Male: yes
26Italy;United Kingdom
107EUCTR2004-002407-32-IT
(EUCTR)
21/10/200416/09/2004\\Extension to a multicenter, open label study to assess the safety and efficacy of 600 micrograms SOM230, administered subcutaneously, b.i.d. in patients with Cushing's disease Treatment of Cushing's disease
MedDRA version: 14.1;Level: PT;Classification code 10035109;Term: Pituitary-dependent Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: NA
Product Code: SOM230B
INN or Proposed INN: PASIREOTIDE
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
26United Kingdom;Italy
108NCT00088608
(ClinicalTrials.gov)
April 200430/7/2004A Study to Assess SOM230 in Patients With Pituitary Cushing's DiseaseA Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in Patients With Cushing's DiseaseCushing's SyndromeDrug: SOM230 s.c.Novartis PharmaceuticalsNULLCompleted18 Years80 YearsBoth26Phase 2United States;France;Italy;United Kingdom
109EUCTR2017-002840-34-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