Levoketozonazole ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
75クッシング病15

75. クッシング病


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
1EUCTR2017-004647-20-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
2EUCTR2017-004647-20-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
3EUCTR2017-004647-20-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
4EUCTR2017-004647-20-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
5EUCTR2017-004647-20-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
6EUCTR2017-004647-20-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
7EUCTR2017-001219-35-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
8EUCTR2017-001219-35-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
9EUCTR2017-001219-35-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
10EUCTR2017-001219-35-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
11EUCTR2017-001219-35-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
12EUCTR2017-001219-35-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
13EUCTR2017-001219-35-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
14EUCTR2017-001219-35-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
15EUCTR2017-001219-35-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