75. クッシング病 Cushing disease Clinical trials / Disease details


臨床試験数 : 203 薬物数 : 191 - (DrugBank : 51) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 128

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04569591
(ClinicalTrials.gov)
March 24, 202229/9/2020Corticotrophin-releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing s DiseaseCorticotrophin-Releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's DiseaseCushing's Disease;Pituitary AdenomaDrug: ActhrelNational Institute of Neurological Disorders and Stroke (NINDS)NULLNot yet recruiting8 YearsN/AAll22N/AUnited States
2NCT04339751
(ClinicalTrials.gov)
March 24, 20228/4/2020Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s DiseaseThe Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing's DiseaseCushing's DiseaseDrug: VorinostatNational Institute of Neurological Disorders and Stroke (NINDS)NULLNot yet recruiting18 YearsN/AAll22Phase 2United States
3EUCTR2020-005605-93-IT
(EUCTR)
21/12/202122/10/2021Efficacy and safety of Silycus® in Cushing’s disease: a multicenter, single arm, openlabel, dose titration, proof of concept study (Silycus®-21)Efficacy and safety of Silycus® in Cushing’s disease: a multicenter, single arm, openlabel, dose titration, proof of concept study (Silycus®-21) - SILYCUS-21 Trial Cushing's disease
MedDRA version: 20.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Silycus
Product Code: [na]
ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 2Italy
4EUCTR2019-004019-29-IT
(EUCTR)
15/07/202107/10/2020Italian study to evaluate the efficacy of retinoic acid and cabergoline therapy in combination in Cushing's disease.Medical combination therapy with retinoic acid and cabergoline in ACTH-secreting pituitary adenoma: a prospective and randomized study. - CRACCA Cushing's disease in patients in whom pituitary surgery has not been curative or in situations where it is contraindicated or refused by patient.
MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Dostinex
Product Name: Cabergolina
Product Code: [G02CB03]
INN or Proposed INN: CABERGOLINA
Other descriptive name: NON COMMERCIAL
Trade Name: VESANOID
Product Name: Tretinoina
Product Code: [L01XX14]
INN or Proposed INN: TRETINOINA
Other descriptive name: NON COMMERCIAL
Dipartimento di Medicina-DIMED, università di PadovaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Italy
5JPRN-jRCT1021210011
10/06/202110/06/2021A diagnosis of pseudo-Cushing's syndrome using dexamethason/CHR and AlprazolamA diagnosis of pseudo-Cushing's syndrome using dexamethason/CRH and anxiolytic Alprazolam Pseudo Cushing's Syndrome
Glucocorticoid , Stress, dexamethasone suppression test;D003480
In patients suspected of having Cushing's syndrome or pseudo-Cushing's syndrome, we perform two loading tests, DEX/CRH and alprazolam tests, in order to confirm the differential ability of this test.Asari YukoNULLRecruitingNot applicableNot applicableBoth100Phase 2Japan
6EUCTR2018-001616-30-DE
(EUCTR)
22/12/202016/03/2020Extension 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: 24.0;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;Bulgaria;Israel;Netherlands;Germany;Italy
7NCT04486859
(ClinicalTrials.gov)
December 1, 202022/7/2020Postoperative Thrombosis Prevention in Patients With CDA Prospective, Multicenter, Randomized Controlled Study of Postoperative Thrombosis Prevention in Patients With Cushing's DiseaseCushing Disease;DVT;Pulmonary EmbolismDrug: LMWH/Rivaroxaban;Device: IPCHuashan HospitalPeking Union Medical College Hospital;West China HospitalRecruiting18 Years60 YearsAll252N/AChina
8NCT03708900
(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
9EUCTR2018-001616-30-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: 24.0;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
10EUCTR2018-001616-30-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]
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 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): noItaly;Germany;Netherlands;Bulgaria;Israel;Austria;Romania;Spain;Poland;Canada;Hungary;United States
11EUCTR2018-001522-25-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
12EUCTR2017-002840-34-NL
(EUCTR)
14/11/201931/07/2019Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Portugal;United States;Spain;Costa Rica;Thailand;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Netherlands;China;Japan;Korea, Republic of
13EUCTR2018-001522-25-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
14EUCTR2018-003096-35-DE
(EUCTR)
04/09/201914/06/2019A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE Endogenous Cushing syndrome
MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Relacorilant
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
145Phase 3United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy
15EUCTR2017-004647-20-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
16EUCTR2017-002840-34-FR
(EUCTR)
08/07/201914/06/2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
17EUCTR2018-003096-35-PL
(EUCTR)
05/07/201912/04/2019A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE Endogenous Cushing syndrome
MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Name: Relacorilant
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
145Phase 3United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy
18EUCTR2018-001522-25-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
19NCT03974789
(ClinicalTrials.gov)
July 1, 20193/6/2019Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of HypercorticismsDiscriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation StudyCushing DiseaseDiagnostic Test: Blood test;Diagnostic Test: 24-hour Urine test;Diagnostic Test: Saliva swab;Diagnostic Test: Dexamethasone testCentre Hospitalier Universitaire de NimesNULLRecruiting18 YearsN/AAll380Phase 3France
20EUCTR2018-003096-35-NL
(EUCTR)
19/06/201911/12/2018A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - CORT125134-455 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 Name: Relacorilant
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
130Phase 3United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Germany;Netherlands;Italy
21EUCTR2017-002840-34-BG
(EUCTR)
18/06/201907/09/2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Portugal;Greece;Thailand;Costa Rica;Spain;Russian Federation;Colombia;Italy;Switzerland;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
22EUCTR2018-001522-25-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
23EUCTR2018-003096-35-BG
(EUCTR)
05/06/201928/01/2019A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE 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 Name: Relacorilant
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
145Phase 3United States;Canada;Spain;Poland;Romania;Austria;Israel;Bulgaria;Netherlands;Germany;Italy
24EUCTR2018-003096-35-AT
(EUCTR)
31/05/201915/02/2019A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE 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 Name: Relacorilant
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
145Phase 3United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy
25EUCTR2018-003096-35-ES
(EUCTR)
23/05/201912/04/2019A study to assess whether a product call relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE 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 Name: Relacorilant
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 finished Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Austria;Israel;Bulgaria;Netherlands;Germany;Italy
26EUCTR2018-001522-25-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 2Italy;United Kingdom;Bulgaria;Belgium;Spain;Slovenia;United States
27NCT04844164
(ClinicalTrials.gov)
April 16, 20199/4/2021Vitamin D Metabolism in Patients With Endocrine DisordersProspective Non-randomised Controlled Study of Vitamin D Metabolism in Patients With Endocrine Disorders (Acromegaly, Cushing's Disease, Primary Hyperparathyroidism, Diabetes Mellitus Type 1) Treated With Cholecalciferol Bolus DosePituitary ACTH Hypersecretion;Acromegaly;Diabetes Mellitus, Type 1;Primary HyperparathyroidismDrug: Cholecalciferol 15000 UNT/ML Oral SolutionEndocrinology Research Centre, MoscowRussian Science FoundationRecruiting18 Years60 YearsAll240Phase 1Russian Federation
28EUCTR2017-004647-20-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
29EUCTR2018-001522-25-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
30EUCTR2018-003096-35-IT
(EUCTR)
21/02/201927/01/2021A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo.Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE 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 Name: Relacorilant
Product Code: [CORT125134]
INN or Proposed INN: Relacorilant
Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-
CORCEPT THERAPEUTICSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Phase 3United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy
31EUCTR2017-004647-20-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
32EUCTR2017-002840-34-BE
(EUCTR)
07/02/201916/11/2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
33EUCTR2017-004647-20-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]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
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
34EUCTR2017-004647-20-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]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
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
35NCT03621280
(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 ABNULLActive, not recruiting18 YearsN/AAll60Phase 3United States;Bulgaria;France;Greece;Hungary;Israel;Italy;Netherlands;Poland;Romania;Spain;Denmark;Turkey
36EUCTR2017-004647-20-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
37NCT03774446
(ClinicalTrials.gov)
November 2, 20186/11/2018Multicenter Study of Seliciclib (R-roscovitine) for Cushing DiseaseA Phase 2 Multicenter Study of Seliciclib (R-roscovitine) for Cushing DiseaseCushing DiseaseDrug: SeliciclibCedars-Sinai Medical CenterNULLRecruiting18 YearsN/AAll29Phase 2United States
38EUCTR2017-002840-34-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
39EUCTR2014-000162-22-RO
(EUCTR)
24/10/201827/07/2021Study 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/ Cormeto
Product Name: metyrapone
INN or Proposed INN: METYRAPONE
Laboratoire HRA PharmaNULLNot RecruitingFemale: yes
Male: yes
55Phase 3Hungary;Spain;Poland;Belgium;Turkey;Romania;Germany;Italy
40NCT03697109
(ClinicalTrials.gov)
October 16, 201827/9/2018A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing SyndromeGlucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of RelacorilantCushing SyndromeDrug: Relacorilant;Other: PlaceboCorcept TherapeuticsNULLRecruiting18 Years80 YearsAll130Phase 3United States;Austria;Bulgaria;Canada;Germany;Israel;Italy;Netherlands;Poland;Romania;Spain
41NCT04045015
(ClinicalTrials.gov)
October 16, 20181/8/2019Liquorice and Salivary CortisolEffects of Liquorice on Salivary Cortisol and CortisoneCushing Syndrome;HypercortisolismDietary Supplement: LiqouriceUmeå UniversityNULLRecruiting18 Years65 YearsAll30N/ASweden
42NCT03606408
(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
43EUCTR2017-002840-34-IT
(EUCTR)
01/10/201817/06/2021Roll-over study to assess long-term safety in patients with endogenous Cushing's syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat - NA Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Osilodrostat 1mg
Product Code: [LCI699]
INN or Proposed INN: Osilodrostat
Product Name: Osilodrostat 5mg
Product Code: [LCI699]
INN or Proposed INN: Osilodrostat
Product Name: Osilodrostat 10mg
Product Code: [LCI699]
INN or Proposed INN: Osilodrostat
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Portugal;Greece;Thailand;Costa Rica;Spain;Russian Federation;Colombia;Italy;Switzerland;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany
44EUCTR2017-002840-34-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
45EUCTR2018-001616-30-IT
(EUCTR)
19/07/201829/01/2021Extension 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]
Trade Name: NA
Product Name: NA
Product Code: [CORT125134]
INN or Proposed INN: Relacorilant
CORCEPT THERAPEUTICSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Hungary;Spain;Bulgaria;Germany;Italy
46EUCTR2017-002840-34-DE
(EUCTR)
13/07/201829/05/2018Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat studyAn open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat Cushing's syndrome
MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Recordati AGNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Portugal;United States;Spain;Costa Rica;Thailand;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of
47EUCTR2018-001616-30-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
48EUCTR2017-001219-35-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]
Product Name: levoketoconazole
Product Code: COR-003
INN or Proposed INN: levoketozonazole
Cortendo ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 3France;United States;Hungary;Greece;Spain;Poland;Romania;Denmark;Bulgaria;Israel;Netherlands;Italy
49JPRN-jRCTs021180039
24/05/201826/03/2019The usefulness of DDAVP test and GHRP-2 test in patients with Cushing's diseaseThe usefulness of DDAVP test and GHRP-2 test in patients with Cushing's disease - Cushing_diagnosis Cushing's diseaseadministration of DDAVP or GHRP-2Kageyama KazunoriNULLRecruiting>= 15age oldNot applicableBoth15Phase 3Japan
50EUCTR2017-001219-35-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
51EUCTR2017-001219-35-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
52NCT03604198
(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;Germany;Israel;Italy;Romania;Spain
53EUCTR2017-001219-35-IT
(EUCTR)
20/02/201827/01/2021A 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
54EUCTR2017-001219-35-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
55EUCTR2017-001219-35-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
56EUCTR2017-001219-35-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
57EUCTR2017-001219-35-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: 24.0;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 3Denmark;Bulgaria;Israel;Netherlands;Italy;France;United States;Hungary;Greece;Spain;Poland;Romania
58EUCTR2017-001219-35-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
59EUCTR2013-000267-84-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
60NCT03346954
(ClinicalTrials.gov)
December 11, 201715/11/2017Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's DiseaseImpact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's DiseaseCushing's DiseaseOther: [11C]-Methionine PET/MRIHospices Civils de LyonNULLCompleted18 YearsN/AAll33N/AFrance
61NCT03277690
(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
62ChiCTR-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
63NCT03111810
(ClinicalTrials.gov)
May 25, 201717/3/2017Targeting Iatrogenic Cushing's Syndrome With 11ß-hydroxysteroid Dehydrogenase Type 1 InhibitionTargeting Iatrogenic Cushing's Syndrome With 11ß-hydroxysteroid Dehydrogenase Type 1 Inhibition (TICSI)Iatrogenic Cushing's DiseaseDrug: AZD4017 and prednisolone;Drug: Placebo Oral Tablet and prednisoloneUniversity of OxfordAstraZenecaCompleted18 Years60 YearsMale32Phase 2United Kingdom
64EUCTR2016-002240-17-GB
(EUCTR)
16/05/201706/03/2017A Study of ATR-101 for the Treatment of Cushing’s SyndromeA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing’s Syndrome endogenous Cushing’s syndrome
MedDRA version: 20.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: ATR-101
INN or Proposed INN: Nevanimibe hydrochloride
Other descriptive name: ATR-101; CI-984
Millendo Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
16 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;United Kingdom
65EUCTR2013-000267-84-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: 21.0;Level: LLT;Classification code 10007271;Term: Carcinoid tumor;System Organ Class: 100000004864
MedDRA version: 21.0;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864
MedDRA version: 20.0;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;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: 21.1;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
Recordati AGNULLNot RecruitingFemale: yes
Male: yes
220Phase 4Portugal;United States;Taiwan;Greece;Spain;Thailand;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of
66NCT03145285
(ClinicalTrials.gov)
April 18, 201726/4/2017Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical CarcinomaActivity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical CarcinomaCushing Syndrome;Adrenocortical CarcinomaDrug: Abiraterone AcetateAzienda Ospedaliera Spedali Civili di BresciaFondazione IRCCS Istituto Nazionale dei Tumori, Milano;Niguarda Hospital;San Camillo Hospital, Rome;San Luigi Gonzaga HospitalActive, not recruiting18 YearsN/AAll10Phase 2Italy
67NCT03053271
(ClinicalTrials.gov)
April 13, 20176/2/2017A Study of ATR-101 for the Treatment of Endogenous Cushing's SyndromeA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing's SyndromeCushing SyndromeDrug: ATR-101;Drug: PlaceboMillendo Therapeutics US, Inc.NULLTerminated18 Years80 YearsAll4Phase 2United States;United Kingdom
68EUCTR2016-003060-40-GB
(EUCTR)
17/01/201722/12/2016Treating side effects of steroid medicationTargeting Iatrogenic Cushing’s Syndrome with 11ß-hydroxysteroid dehydrogenase type 1 Inhibition - TICSI version 0.6 Adverse effects of prescribed glucocorticoid therapy
MedDRA version: 19.0;Level: LLT;Classification code 10068501;Term: Cushing's syndrome, steroid-induced;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: AZD4017
Product Code: AZD4017
INN or Proposed INN: no INN available
Other descriptive name: AZD4017
University of Oxford, Clinical Trials and Research GovernanceNULLNot RecruitingFemale: no
Male: yes
32Phase 2United Kingdom
69EUCTR2016-000899-23-NL
(EUCTR)
20/12/201627/07/2016Clinical trial to assess the safety and effectiveness of a study drug called CORT125134 in the treatment of Cushing's syndromePhase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing’s 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: Not Available
Corcept Therapeutics IncorporatedNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Hungary;Netherlands;United Kingdom
70EUCTR2015-004497-15-IT
(EUCTR)
12/12/201608/01/2018Endocrine cardiomyopathy in cushing syndrome: Response to cyclic GMP PDE5 inhibitOrsStudy on New Insights in Remodeling of Endocrine Cardiomyopathies: Intramyocardial, Molecular and Neuroendocrine Assessment in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A in Cushing’s Syndrome-Endocrine cardiomyopathy in cushing syndrome: Response to cyclic GMP PDE5 inhibitOrs - Endocrine cardiomyopathy in cushing syndrome: Response to cyclic GMP PDE5 inhibitOrs 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: CIALIS - 20 MG 2 COMPRESSE RIVESTITE CON FILM IN BLISTER USO ORALE
Product Name: Tadalafil
UMBERTO I - POLICLINICO DI ROMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 2Italy
71EUCTR2016-000899-23-IT
(EUCTR)
08/11/201608/06/2021Clinical trial to assess the safety and effectiveness of a study drug called CORT125134 in the treatment of Cushing's syndromePhase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing¿s Syndrome - - Endogenous Cushing¿s Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860
MedDRA version: 20.0;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07]
Product Code: CORT125134CORCEPT THERAPEUTICSNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Hungary;Netherlands;United Kingdom;Italy
72EUCTR2014-004092-23-PT
(EUCTR)
14/10/201603/08/2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
69Phase 3United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Belgium;Brazil;Poland;China
73EUCTR2016-000899-23-HU
(EUCTR)
05/10/201630/06/2016Clinical trial to assess the safety and effectiveness of a study drug called CORT125134 in the treatment of Cushing's syndromePhase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing’s 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: Not Available
Corcept Therapeutics IncorporatedNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Hungary;Netherlands;United Kingdom
74NCT02697734
(ClinicalTrials.gov)
October 3, 201627/2/2016Efficacy and Safety Evaluation of Osilodrostat in Cushing's DiseaseA Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's DiseaseCushing's DiseaseDrug: osilodrostat;Drug: osilodrostat PlaceboNovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll73Phase 3United States;Belgium;Brazil;Canada;China;Costa Rica;Greece;Poland;Portugal;Russian Federation;Spain;Switzerland;Thailand;Turkey
75EUCTR2014-004092-23-PL
(EUCTR)
08/09/201625/07/2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
69Phase 3United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Poland;Belgium;Brazil;Denmark;China
76EUCTR2016-000899-23-GB
(EUCTR)
16/08/201621/06/2016Clinical trial to assess the safety and effectiveness of a study drug called CORT125134 in the treatment of Cushing's syndromePhase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s Syndrome Endogenous Cushing’s 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
Corcept Therapeutics IncorporatedNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Netherlands;United Kingdom
77EUCTR2014-004092-23-BE
(EUCTR)
09/08/201618/05/2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
69Phase 3United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Belgium;Brazil;Poland;China
78EUCTR2014-000162-22-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]
Trade Name: Metopirone 250 mg capsules
Product Name: metyrapone
INN or Proposed INN: METYRAPONE
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
79EUCTR2014-004092-23-GR
(EUCTR)
05/07/201611/05/2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 Cushing's disease
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
69Phase 3Portugal;United States;Greece;Thailand;Spain;Poland;Brazil;Belgium;Turkey;Denmark;Russian Federation;Switzerland
80NCT02611258
(ClinicalTrials.gov)
July 201616/11/2015Endocrine Cardiomyopathy in Cushing Syndrome: Response to Cyclic GMP PDE5 inhibitOrsStudy on New Insights in Remodeling of Endocrine Cardiomyopathies: Intramyocardial, Molecular and Neuroendocrine Assessment in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A in Cushing's SyndromeCushing's Syndrome CardiomyopathyDrug: TadalafilAndrea M. IsidoriNULLUnknown status18 Years75 YearsAll18Phase 2Italy
81EUCTR2016-000945-29-IT
(EUCTR)
16/06/201604/11/2020Activity of Abiraterone Acetate in the management of Cushing’s syndrome in patients with adrenocortical carcinoma (ABACUS)Activity of Abiraterone Acetate in the management of Cushing’s syndrome in patients with adrenocortical carcinoma (ABACUS) - ABACUS Cushing’s syndrome in patients with adrenocortical carcinoma
MedDRA version: 20.0;Level: PT;Classification code 10001388;Term: Adrenocortical carcinoma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: ZYTIGA - 250 MG - COMPRESSA - USO ORALE - FLACONE 120 COMPRESSE
Product Name: ZYTIGA
Product Code: [ZYTIGA]
INN or Proposed INN: abiraterone acetato
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Italy
82NCT02804750
(ClinicalTrials.gov)
June 201615/6/2016Study to Evaluate CORT125134 in Participants With Cushing's SyndromePhase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's SyndromeCushing's SyndromeDrug: CORT125134Corcept TherapeuticsNULLCompleted18 Years80 YearsAll35Phase 2United States;Hungary;Italy;Netherlands;United Kingdom
83EUCTR2014-004092-23-ES
(EUCTR)
29/04/201618/03/2016Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's DiseaseA Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing?s disease - LINC-4 Cushing's disease
MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Product Name: osilodrostat 20mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
69Phase 3United States;Greece;Poland;Brazil;Belgium;Thailand;Spain;Turkey;Denmark;Russian Federation;Switzerland
84EUCTR2013-002133-37-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]
Product Name: COR-003
Product Code: COR-003
INN or Proposed INN: Not available
Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole
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
85EUCTR2013-002133-37-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]
Product Name: COR-003
Product Code: COR-003
INN or Proposed INN: Not available
Other descriptive name: 2S,4R-(-)-ketoconazole
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
86EUCTR2013-000267-84-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
87EUCTR2013-002133-37-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]
Product Name: COR-003
Product Code: COR-003
INN or Proposed INN: Not available
Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole
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
88EUCTR2014-000162-22-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
89JPRN-UMIN000018891
2015/10/0101/10/2015The usefulness of DDAVP test and GHRP-2 test in patients with Cushing's disease Cushing's diseaseadministration of DDAVP or GHRP-2Department of Endocrinology and Metabolism, Hirosaki University Graduate School of MedicineNULLRecruiting15years-oldNot applicableMale and Female15Not selectedJapan
90NCT02468193
(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
91EUCTR2013-002133-37-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
92EUCTR2013-002133-37-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
93EUCTR2012-002916-16-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
94NCT02484755
(ClinicalTrials.gov)
June 201521/6/2015Targeted Therapy With Gefitinib in Patients With USP8-mutated Cushing's DiseaseTargeted Therapy With Gefitinib in Patients With USP8-mutated Cushing's DiseaseCushing's Disease;Corticotrophin AdenomaDrug: GefitinibHuashan HospitalNULLRecruiting18 Years70 YearsBoth6Phase 2China
95EUCTR2014-000162-22-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;Spain;Poland;Belgium;Turkey;Romania;Germany;Italy
96EUCTR2012-002916-16-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
97NCT02297945
(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
98EUCTR2013-002170-49-NL
(EUCTR)
25/03/201517/12/2014A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease Cushing's disease
MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
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: Dostinex
Product Name: Cabergoline
INN or Proposed INN: cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands
99EUCTR2014-000162-22-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
100EUCTR2013-000267-84-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
101EUCTR2014-000162-22-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
102EUCTR2014-000162-22-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
103EUCTR2013-004766-34-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
104NCT02574793
(ClinicalTrials.gov)
December 1, 20149/10/2015Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome SubjectsCharacteristics of Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome SubjectsPituitary AdenomaDevice: continuous glucose monitoringHuashan HospitalNULLCompletedN/AN/AAll60China
105EUCTR2013-004766-34-FR
(EUCTR)
28/11/201408/02/2019Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's diseaseA Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04]Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 20mg
Product Code: LCI699
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of
106EUCTR2013-004766-34-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
107EUCTR2013-002133-37-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]
Product Name: COR-003
INN or Proposed INN: Not available
Other descriptive name: 2S,4R-(-)-ketoconazole
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
108EUCTR2013-002133-37-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]
Product Name: COR-003
INN or Proposed INN: Not available
Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole
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
109EUCTR2013-004766-34-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
110NCT02180217
(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
111EUCTR2013-002133-37-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]
Product Name: COR-003
Product Code: COR-003
INN or Proposed INN: Not available
Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole
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
112EUCTR2012-002916-16-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]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 300micrograms
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 600 micrograms
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 900 micrograms
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE DIASPARTATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR, 20 mg
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
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
113EUCTR2013-004766-34-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
114EUCTR2013-004766-34-AT
(EUCTR)
05/08/201431/07/2014Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's diseaseA Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease Cushing's disease
MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: osilodrostat 1mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 5mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 10mg
Product Code: LCI699
INN or Proposed INN: osilodrostat
Other descriptive name: LCI699
Product Name: osilodrostat 20mg
Product Code: LCI699
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of
115EUCTR2013-004766-34-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.NULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Korea, Republic of;Japan;China;Germany;Netherlands;Bulgaria;Australia;Argentina;Canada;France;India;Italy;United Kingdom;Colombia;Russian Federation;Austria;Turkey;Spain;Thailand;Slovakia;Taiwan
116NCT01838551
(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: LevoketoconazoleCortendo 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
117EUCTR2013-002133-37-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]
Product Name: COR-003
Product Code: COR-003
INN or Proposed INN: Not available
Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole
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
118EUCTR2013-002133-37-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
119EUCTR2012-002916-16-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
120JPRN-UMIN000041513
2014/07/0101/09/2020A new perioperative glucocorticosteroid replacement therapy for cushing syndromeA new perioperative glucocorticosteroid replacement therapy for cushing syndrome - A perioperative glucocorticosteroid replacement therapy PerioperativeHydrocortisone was given during adrenal resection by intravenous injectionon the surgical day.Tianjin Medical University General HospitalNULLRecruiting22years-old61years-oldMale and Female80Not selectedAsia(except Japan)
121EUCTR2013-002133-37-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]
Product Name: COR-003
INN or Proposed INN: Not available
Other descriptive name: 2S,4R-(-)-ketoconazole
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
122NCT02060383
(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
123NCT02160730
(ClinicalTrials.gov)
May 201421/5/2014Treatment of Cushing's Disease With R-roscovitineTreatment of Pituitary Cushing Disease With a Selective CDK Inhibitor, R-roscovitineCushings DiseaseDrug: R-roscovitineShlomo Melmed, MDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Terminated18 YearsN/AAll4Phase 2United States
124EUCTR2013-002170-49-BE
(EUCTR)
19/03/201404/12/2013 A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline 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
Trade Name: Signifor
Product Name: pasireotide 0.3mg
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide 0.6mg
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide 0.9 mg
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
125NCT01915303
(ClinicalTrials.gov)
March 6, 201410/6/2013Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's DiseaseA Phase II Trial to Assess the Efficacy and Safety of Pasireotide s.c. Alone or in Combination With Cabergoline in Patients With Cushing's DiseaseCushings DiseaseDrug: Pasireotide with or without cabergolineNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll68Phase 2United States;Argentina;Belgium;Brazil;Colombia;France;Germany;Greece;Hungary;India;Italy;Malaysia;Mexico;Netherlands;Spain;Turkey;Australia;Bulgaria;Venezuela
126NCT02019706
(ClinicalTrials.gov)
February 12, 201421/12/2013Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing SyndromeEvaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing SyndromeACTH;Cushing's SyndromeRadiation: DOTATATE PET-CT;Radiation: F-DOPA PET CT;Radiation: CT scan;Diagnostic Test: Routine MRI scan;Diagnostic Test: Gated MRI scan;Drug: 68Ga-DOTATATE;Drug: 18F-DOPAEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years80 YearsAll80Phase 2United States
127EUCTR2013-002170-49-HU
(EUCTR)
03/02/201413/12/2013A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease Cushing's disease
MedDRA version: 18.0;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 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: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
64Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
128EUCTR2013-002170-49-GR
(EUCTR)
29/01/201424/01/2014A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease Cushing's diseaseProduct Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany
129EUCTR2013-002170-49-IT
(EUCTR)
21/01/201422/10/2013Study of the efficacy and safety of pasireotide s.c. +/- cabergoline in patients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease Cushing's disease
MedDRA version: 14.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: NA
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: NA
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: NA
Trade Name: Dostinex
Product Name: Cabergoline
Product Code: NA
INN or Proposed INN: cabergoline
Other descriptive name: NA
NOVARTIS FARMA S.p.A.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany
130EUCTR2013-002170-49-FR
(EUCTR)
27/12/201303/12/2015A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease Cushing's diseaseProduct Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: CABERGOLINE TEVA
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
131EUCTR2013-002170-49-ES
(EUCTR)
21/11/201312/11/2013A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s diseaseA Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s disease Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: SIGNIFOR
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: SIGNIFOR
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: SIGNIFOR
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
INN or Proposed INN: CABERGOLINE
Other descriptive name: CABERGOLINE
Novartis Farmacéutica , S.A.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
132EUCTR2013-002170-49-DE
(EUCTR)
19/11/201317/09/2013A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's diseaseA Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline 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] - 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: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
64Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany
133EUCTR2013-002063-26-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
134EUCTR2013-000267-84-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
135NCT01925092
(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
136NCT01794793
(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
137EUCTR2013-000267-84-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
138EUCTR2013-000267-84-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
139NCT03080181
(ClinicalTrials.gov)
May 20133/3/2017Adipokine Profile in Patients With Cushing's Disease on Pasireotide TreatmentAdipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion ParametersCushing DiseaseDrug: Pasireotide 0.6 MG/MLUniversity of PalermoNULLCompleted18 YearsN/AAll24Phase 4NULL
140NCT02310269
(ClinicalTrials.gov)
March 28, 201326/9/2014Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's DiseaseNon-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)Cushings DiseaseDrug: SOM230RECORDATI GROUPNULLRecruiting18 YearsN/AAll200United States;Canada;Colombia;France;Germany;Israel;Italy;Lebanon;Netherlands;Romania;Sweden;United Kingdom;Denmark
141NCT01319994
(ClinicalTrials.gov)
July 201221/2/2011Prevention of Metabolic Complications of Glucocorticoid ExcessPrevention of Metabolic Complications of Glucocorticoid Excess - a Randomised, Doubleblind,Placebo Controlled StudyIatrogenic Cushing DiseaseDrug: Metformin;Drug: PlaceboBarts & The London NHS TrustBarts and the London School of Medicine and DentistryCompleted18 Years75 YearsAll57Phase 2/Phase 3United Kingdom
142EUCTR2010-024165-44-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
143NCT02889224
(ClinicalTrials.gov)
February 201230/8/2016In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in ManIn Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in ManCushing's SyndromeOther: Obese;Procedure: Hypercortisolism;Other: Hydrocortisone;Other: ControlUniversity Hospital, BordeauxNULLCompleted18 YearsN/AAll40N/AFrance
144EUCTR2009-011128-70-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
145NCT01374906
(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
146EUCTR2011-003264-77-NL
(EUCTR)
31/10/201107/09/2011A study with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease.A prospective trial with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease. - Octreotide and ketoconazole for Cushing's disease Cushing's disease (which is caused by an ACTH producing pituitary adenoma)
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]
Trade Name: Octreotide
Product Name: Octreotide
Product Code: RVG 18236
Trade Name: Ketoconazole
Product Name: Ketoconazole
Product Code: RVG 08938
Trade Name: Cabergoline
Product Name: Cabergoline
Product Code: RVG 15375
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
147EUCTR2009-011128-70-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
148EUCTR2009-011128-70-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
149NCT01459237
(ClinicalTrials.gov)
October 11, 201121/10/2011Effects of Hormone Stimulation on Brain Scans for Cushing s DiseaseProspective Evaluation of the Effect of Corticotropin-Releasing Hormone Stimulation on 18F-Fludeoxyglucose High-Resolution Positron-Emission Tomography in Cushing's DiseasePituitary NeoplasmDrug: ActhrelNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted8 YearsN/AAll30Early Phase 1United States
150EUCTR2009-011128-70-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
151EUCTR2009-011128-70-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
152EUCTR2009-011128-70-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;Japan;China;Germany;Peru;Singapore;Brazil;Belgium;Poland;Argentina;Canada;United Kingdom;Italy;Russian Federation
153EUCTR2010-024165-44-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
154EUCTR2009-011128-70-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
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
INN or Proposed INN: pasireotide
INN or Proposed INN: pasireotide
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
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
155EUCTR2010-024165-44-ES
(EUCTR)
22/08/201107/07/2011Estudio en el que se sabe qué fármaco toma cada paciente, llevado a cabo en varios hospitales, con Pasireotida subcutánea en pacientes con enfermedad de CushingEstudio abierto, multicéntrico, de acceso expandido de pasireotida s.c., en pacientes con enfermedad de Cushing Enfermedad de Cushing
MedDRA version: 14.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders
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: Pasireotida 300
Product Code: SOM230
INN or Proposed INN: Pasireotida
Product Name: Pasireotida 600
Product Code: SOM230B
INN or Proposed INN: Pasireotida 600
Other descriptive name: SOM230B
Product Name: Pasireotida 900
Product Code: SOM230B
INN or Proposed INN: Pasireotida 900
Other descriptive name: SOM230B
Product Name: Pasireotida 300
Product Code: SOM230
INN or Proposed INN: Pasireotida
Product Name: Pasireotida 600
Product Code: SOM230B
INN or Proposed INN: Pasireotida 600
Other descriptive name: SOM230B
Product Name: Pasireotida 900
Product Code: SOM230B
INN or Proposed INN: Pasireotida 900
Other descriptive name: SOM230B
Product Name: Pasireotida 300
Product Code: SOM230
INN or Proposed INN: Pasireotida
Product Name: Pasireotida 600
Product Code: SOM230B
INN or Proposed INN: Pasireotida 600
Other descriptive name: SOM230B
Product Name: Pasireotida 900
Product Code: SOM230B
INN or Proposed INN: Pasireotida 900
Other descriptive name: SOM230B
NOVARTIS FARMACEUTICA S.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Egypt;Hungary;Czech Republic;Greece;Argentina;Brazil;Thailand;Spain;Romania;Netherlands;Germany;Korea, Republic of
156NCT01582061
(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
157EUCTR2010-024165-44-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
158EUCTR2010-024165-44-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
159EUCTR2010-022403-22-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
160NCT01331239
(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
161NCT01371565
(ClinicalTrials.gov)
November 20107/6/2011Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's SyndromeCompassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's SyndromeCushing's Disease;Cushing's SyndromeDrug: MifepristoneCorcept TherapeuticsNULLCompleted18 YearsN/AAll4Phase 3United States
162EUCTR2008-005708-18-GB
(EUCTR)
04/06/201014/04/2010Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excessPrevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess Rheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndromeTrade Name: Glucophage (metformin)
Product Name: Metformin
Queen Mary University of LondonNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
163EUCTR2010-018720-12-SE
(EUCTR)
22/04/201018/02/2010Behandling med kabergolin hos patienter med ACTH-beroende Cushing´s syndrom(treatment with cabergoline in patients with ACTH-dependent Cushing´s syndrome - Cushing and cabergolineBehandling med kabergolin hos patienter med ACTH-beroende Cushing´s syndrom(treatment with cabergoline in patients with ACTH-dependent Cushing´s syndrome - Cushing and cabergoline A) Men and women aged 18 to 75 years with hypercortisolism due to ACTH-dependent Cushing's syndrome will be treated in the period between diagnosis and planned surgery or radiation therapy.B) Men and women aged 18 to 75 years due to ACTH-dependent Cushing's syndrome who have persistent hypercortisolism post-surgery or post-radiotherapy.Product Name: cabergolineSwedish Pituitary Study groupNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Sweden
164JPRN-UMIN000002925
2009/12/0128/12/2009Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension.Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension. - A pilot study to compare efficacy of Eplerenone monotherapy with Valsartan monotherapy. Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension.50mg of Eplerenone monotherapy once daily for 6 weeks on subclinical Cushing's syndrome
80mg of Valsartan monotherapy once daily for 6 weeks on subclinical Cushing's syndrome
50mg of Eplerenone monotherapy once daily for 6 weeks on non-functioning adrenocortical adenoma
80mg of Valsartan monotherapy once daily for 6 weeks on non-functioning adrenocortical adenoma
Hiroshima University HospitalDepartment of Endocrinology and Diabetes mellitusNULLComplete: follow-up complete20years-oldNot applicableMale and Female80Not selectedJapan
165EUCTR2009-010918-30-IE
(EUCTR)
11/08/200911/03/2009Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism.Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. 20 patients with hypopituitarism including growth hormone deficiency will be evaluated both on growth hormone replacement and when they have been off it for a 2 month period. They will have been prescribed growth hormone replacement in the form of Genotropin/Genotropin Miniquick/Norditropin prior to inclusion in this study as part of their routine clinical care.
MedDRA version: 9.1;Level: LLT;Classification code 10021067;Term: Hypopituitarism
MedDRA version: 9.1;Classification code 10033662;Term: Panhypopituitarism
MedDRA version: 9.1;Classification code 10056438;Term: Growth hormone deficiency
MedDRA version: 9.1;Classification code 10011318;Term: Craniopharyngioma
MedDRA version: 9.1;Classification code 10036832;Term: Prolactinoma
MedDRA version: 9.1;Classification code 10011651;Term: Cushing's disease
MedDRA version: 9.1;Classification code 10035104;Term: Pituitary tumour
MedDRA version: 9.1;Classification code 10061538;Term: Pituitary tumour benign
Trade Name: Genotropin 5.3mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin 12mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.2mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.4mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.6mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 0.8mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 1.0mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniquick 1.2mg
INN or Proposed INN: SOMATROPIN
Trade Name: Genotropin Miniqu
Amar Agha, Beaumont HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Ireland
166NCT00936741
(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
167EUCTR2007-007604-15-GB
(EUCTR)
03/03/200921/08/2008A Pilot Study of the Effect of Glucocorticoid Receptor Antagonism in Patients with Sub-Clinical Cushing's Syndrome - Glucocorticoid Receptor Antagonism in Sub-Clinical CushingsA Pilot Study of the Effect of Glucocorticoid Receptor Antagonism in Patients with Sub-Clinical Cushing's Syndrome - Glucocorticoid Receptor Antagonism in Sub-Clinical Cushings Sub Clinical Cushing's Syndrome
MedDRA version: 9.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome
Trade Name: mifedren
Product Name: HRA052015 (mifepristone)
Product Code: HRA052015
INN or Proposed INN: MIFEPRISTONE
Sheffield Teaching Hospitals NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
6 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
168NCT00796783
(ClinicalTrials.gov)
February 200920/11/2008A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of HypercortisolemiaA Study to Confirm the Presence of Recurrent or Persistent Cushing's Syndrome in Patients With Clinical Signs or Symptoms of Hypercortisolemia Who Have Been Treated for Cushing's DiseaseCushing's SyndromeDrug: Cushing's syndrome confirmationCorcept TherapeuticsNULLTerminated18 YearsN/ABoth2N/AUnited States
169NCT00721201
(ClinicalTrials.gov)
November 200821/7/2008Glucocorticoid Receptor Antagonism in Subclinical CushingsA Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical CushingsSubclinical Cushing'sDrug: MifepristoneSheffield Teaching Hospitals NHS Foundation TrustHRA PharmaCompleted18 YearsN/AAll6Phase 1/Phase 2United Kingdom
170NCT00845351
(ClinicalTrials.gov)
November 200816/2/2009Preoperative Bexarotene Treatment for Cushing's DiseasePreoperative Bexarotene Treatment for Cushing's DiseaseCushing's DiseaseDrug: BexaroteneUniversity of VirginiaNULLRecruiting18 Years65 YearsBoth6Phase 1/Phase 2United States
171EUCTR2006-004111-22-HU
(EUCTR)
29/10/200822/07/2008A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
146Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy
172EUCTR2008-006379-65-IT
(EUCTR)
27/10/200812/11/2008Evaluation of the benefit-risk profile of retinoic acid in the treatment of Cushing`s disease - Retinoic acid in Cushing`s diseaseEvaluation of the benefit-risk profile of retinoic acid in the treatment of Cushing`s disease - Retinoic acid in Cushing`s disease sperimentation only in patientsINN or Proposed INN: TretinoinISTITUTO AUXOLOGICO ITALIANONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
173EUCTR2008-002280-14-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
174EUCTR2006-004111-22-GB
(EUCTR)
19/03/200820/03/2008A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
146Phase 3Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;Italy;United Kingdom
175EUCTR2006-004111-22-GR
(EUCTR)
11/12/200730/07/2007A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
146Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
176NCT00569582
(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
177EUCTR2006-004111-22-PT
(EUCTR)
09/11/200727/06/2007A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy
178NCT00889525
(ClinicalTrials.gov)
November 200727/4/2009Study of Cabergoline in Treatment of Corticotroph Pituitary TumorStudy of Cabergoline in Treatment of Corticotroph Pituitary TumorCushing's Disease;Corticotroph AdenomaDrug: CabergolineSeth Gordhandas Sunderdas Medical CollegeNULLCompleted12 YearsN/ABothPhase 3India
179NCT00422201
(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
180EUCTR2006-004111-22-FI
(EUCTR)
04/05/200724/01/2007A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy
181EUCTR2006-004080-55-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
182EUCTR2006-004679-36-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
183EUCTR2006-004111-22-DE
(EUCTR)
04/04/200718/04/2007A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
184NCT00612066
(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
185EUCTR2006-004111-22-FR
(EUCTR)
23/03/200712/02/2007A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotode
Other descriptive name: Cyclo ((diaminoethyl-carbamate)HyPro-Phg-(D) Trp-Ly di-aspartate
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo ((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Ly di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
186EUCTR2006-004679-36-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
187EUCTR2006-004111-22-BE
(EUCTR)
06/03/200714/11/2006A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
146Phase 3Denmark;Germany;United Kingdom;Italy;Portugal;France;Hungary;Greece;Finland;Spain;Belgium
188EUCTR2006-004111-22-ES
(EUCTR)
05/02/200711/08/2014A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing?s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing?s disease Cushing?s disease is a rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing?s disease is a rare disease associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females.
MedDRA version: 17.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Farmaceútica S.A.NULLNot RecruitingFemale: yes
Male: yes
162Portugal;United States;Greece;Finland;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China
189EUCTR2006-004679-36-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
190EUCTR2006-004111-22-DK
(EUCTR)
05/01/200710/11/2006A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s diseaseA randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to produce excess cortisol, leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. Cushing's disease is associated with severe morbidity and premature mortality and most commonly affects adults aged 20-50, primarily females
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Other descriptive name: Cyclo((diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) di-aspartate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
146Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy
191EUCTR2006-004679-36-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
192NCT00434148
(ClinicalTrials.gov)
December 20069/2/2007Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's DiseaseA Randomized, Double-blind Study to Assess the Safety and Efficacy of Different Dose Levels of Pasireotide (SOM230) Subcutaneous (sc) Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's DiseaseCushing's DiseaseDrug: PasireotideNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll162Phase 3United States;Argentina;Belgium;Brazil;Canada;China;Denmark;Finland;France;Germany;Greece;Israel;Italy;Mexico;Poland;Portugal;Spain;Turkey
193EUCTR2006-004111-22-IT
(EUCTR)
23/11/200605/01/2007//A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230)s.c. over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing`s disease de novo or persistent/recurrent Cushing disease
MedDRA version: 14.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
100Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
194EUCTR2006-005218-11-IT
(EUCTR)
15/09/200603/04/2007EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROMEEFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROME Cushing syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10011652;Term: Cushing's syndrome
Trade Name: DOSTINEX
Trade Name: NIZORAL
ASSOCIAZIONE ITALIANA ENDOCRINOLOGIA-METABOLISMO-IPOFISINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
195NCT01959711
(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
196EUCTR2004-002407-32-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
197EUCTR2004-002407-32-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
198NCT00171951
(ClinicalTrials.gov)
August 200413/9/2005Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's DiseaseExtension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's DiseaseCushing DiseaseDrug: PasireotideNovartis PharmaceuticalsNULLCompleted18 YearsN/ABoth19Phase 2United States;France;Germany;Italy;United Kingdom
199NCT00088608
(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
200NCT00001849
(ClinicalTrials.gov)
February 26, 19993/11/1999New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing SyndromeNew Imaging Modalities in the Evaluation of Patients With Ectopic Cushing's SyndromeCushing Syndrome;Endocrine DiseaseDrug: Pentetreotide;Drug: 18F-DOPAEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLCompleted18 Years90 YearsAll98Phase 1/Phase 2United States
201NCT03575247
(ClinicalTrials.gov)
January 1, 199820/6/2018The Risk of Adrenal Insufficiency and Cushing Syndrome Associated With Glucocorticoid Therapy in People With Chronic Inflammatory DiseasesThe Risk of Adrenal Insufficiency and Cushing Syndrome Associated With Glucocorticoid Therapy in People With Chronic Inflammatory DiseasesAdrenal; Insufficiency Gluccorticoid-Induced;Cushing; Syndrome or Disease, Glucocorticoid-InducedDrug: GlucocorticoidsUniversity of LeedsNULLCompleted18 YearsN/AAll111804NULL
202NCT00001180
(ClinicalTrials.gov)
March 19823/11/1999Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal InsufficiencyDose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal InsufficiencyAdrenal Gland Hyperfunction;Adrenal Gland Hypofunction;Cushing's Syndrome;HealthyDrug: Ovine Corticotropin-Releasing Hormone (oCRH)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLCompletedN/AN/ABoth2250N/AUnited States
203EUCTR2017-002840-34-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