2S,4R-(-)-ketoconazole ( DrugBank: Ketoconazole )


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11

75. クッシング病


臨床試験数 : 205 薬物数 : 176 - (DrugBank : 45) / 標的遺伝子数 : 61 - 標的パスウェイ数 : 127
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-002133-37-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
2EUCTR2013-002133-37-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
3EUCTR2013-002133-37-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
4EUCTR2013-002133-37-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
5EUCTR2013-002133-37-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
6EUCTR2013-002133-37-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
7EUCTR2013-002133-37-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
8EUCTR2013-002133-37-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
9EUCTR2013-002133-37-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
10EUCTR2013-002133-37-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
11EUCTR2013-002133-37-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