Levoketoconazole ( DrugBank: Levoketoconazole )


1 disease
IDDisease name (Link within this page)Number of trials
75Cushing disease26

75. Cushing disease


Clinical trials : 203 Drugs : 191 - (DrugBank : 51) / Drug target genes : 62 - Drug target pathways : 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
6NCT03621280
(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
7EUCTR2017-004647-20-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
8EUCTR2017-001219-35-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
9EUCTR2017-001219-35-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
10EUCTR2017-001219-35-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
11EUCTR2017-001219-35-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
12EUCTR2017-001219-35-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
13EUCTR2017-001219-35-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
14EUCTR2017-001219-35-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
15EUCTR2017-001219-35-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
16EUCTR2017-001219-35-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
17NCT03277690
(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
18EUCTR2013-002133-37-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
19EUCTR2013-002133-37-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
20EUCTR2013-002133-37-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
21EUCTR2013-002133-37-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
22EUCTR2013-002133-37-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
23EUCTR2013-002133-37-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
24NCT01838551
(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
25EUCTR2013-002133-37-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
26EUCTR2013-002133-37-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