COR-003 ( 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 | 27 |
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-004647-20-NL (EUCTR) | 29/08/2019 | 23/11/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Greece;Netherlands;Romania;Hungary;United States;Poland;Italy;Israel;Bulgaria;France;Spain | ||
| 2 | EUCTR2017-004647-20-GR (EUCTR) | 21/03/2019 | 19/02/2019 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study 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: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;United States;Hungary;Greece;Spain;Poland;Romania;Denmark;Bulgaria;Israel;Netherlands;Italy | ||
| 3 | EUCTR2017-004647-20-BG (EUCTR) | 11/02/2019 | 24/10/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study 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: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;United States;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 4 | EUCTR2017-004647-20-ES (EUCTR) | 17/01/2019 | 25/10/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An 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 AB | NULL | Authorised-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): no | United States;Greece;Spain;Turkey;Israel;Italy;France;Hungary;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 5 | EUCTR2017-004647-20-IT (EUCTR) | 11/01/2019 | 15/11/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An 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 AB | NULL | Authorised-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): no | United States;Greece;Spain;Turkey;Israel;Italy;France;Hungary;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 6 | EUCTR2017-004647-20-HU (EUCTR) | 13/11/2018 | 26/09/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Greece;Spain;Turkey;Israel;Italy;France;Hungary;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 7 | EUCTR2017-001219-35-NL (EUCTR) | 24/05/2018 | 29/11/2017 | A 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 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | France;United States;Hungary;Greece;Spain;Poland;Romania;Denmark;Bulgaria;Israel;Netherlands;Italy | ||
| 8 | EUCTR2017-001219-35-FR (EUCTR) | 23/05/2018 | 24/10/2017 | A 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 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 9 | EUCTR2017-001219-35-GR (EUCTR) | 08/05/2018 | 04/04/2018 | A 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 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 10 | EUCTR2017-001219-35-IT (EUCTR) | 20/02/2018 | 27/01/2021 | A 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 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 11 | EUCTR2017-001219-35-DK (EUCTR) | 14/02/2018 | 19/12/2017 | A 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 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 12 | EUCTR2017-001219-35-BG (EUCTR) | 23/01/2018 | 30/10/2017 | A 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 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 13 | EUCTR2017-001219-35-ES (EUCTR) | 22/01/2018 | 17/10/2017 | A 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 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 14 | EUCTR2017-001219-35-PL (EUCTR) | 16/01/2018 | 28/11/2017 | A 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 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | Denmark;Bulgaria;Israel;Netherlands;Italy;France;United States;Hungary;Greece;Spain;Poland;Romania | ||
| 15 | EUCTR2017-001219-35-HU (EUCTR) | 12/01/2018 | 16/11/2017 | A 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 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 16 | EUCTR2013-002133-37-HU (EUCTR) | 05/04/2016 | 24/09/2015 | A 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 Disease | An 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 AB | NULL | Not 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): no | Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;Sweden | ||
| 17 | EUCTR2013-002133-37-CZ (EUCTR) | 22/02/2016 | 27/07/2015 | A 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 Disease | An 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 AB | NULL | Not 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): no | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 18 | EUCTR2013-002133-37-BG (EUCTR) | 15/10/2015 | 07/07/2015 | A 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 Disease | An 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 AB | NULL | Not 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): no | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 19 | EUCTR2013-002133-37-DE (EUCTR) | 23/09/2015 | 12/06/2014 | A 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 Disease | An 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Sweden | ||
| 20 | EUCTR2013-002133-37-DK (EUCTR) | 31/07/2015 | 20/03/2014 | A 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 Disease | An 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Sweden | ||
| 21 | EUCTR2013-002133-37-GB (EUCTR) | 17/11/2014 | 18/06/2013 | A 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 Disease | An 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 AB | NULL | Not 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): no | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 22 | EUCTR2013-002133-37-IT (EUCTR) | 17/11/2014 | 04/09/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome | An 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 AB | NULL | Not 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): no | United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Bulgaria;Georgia;Germany;Netherlands;Sweden | ||
| 23 | EUCTR2013-002133-37-SE (EUCTR) | 18/09/2014 | 12/03/2014 | A 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 Disease | An 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 AB | NULL | Not 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): no | Serbia;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 24 | NCT01838551 (ClinicalTrials.gov) | August 2014 | 19/4/2013 | Treatment for Endogenous Cushing's Syndrome | An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome | Endogenous Cushing's Syndrome | Drug: Levoketoconazole | Cortendo AB | NULL | Completed | 18 Years | N/A | All | 90 | Phase 3 | United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Serbia;Spain;Turkey;Czech Republic;Georgia;Hungary;Sweden;Switzerland;United Kingdom |
| 25 | EUCTR2013-002133-37-NL (EUCTR) | 10/07/2014 | 11/03/2014 | A 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 Disease | An 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 AB | NULL | Not 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): no | Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Germany;Netherlands;Sweden | ||
| 26 | EUCTR2013-002133-37-BE (EUCTR) | 09/07/2014 | 11/02/2014 | A 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 Disease | An 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;Sweden | ||
| 27 | EUCTR2013-002133-37-ES (EUCTR) | 26/05/2014 | 12/11/2013 | A 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 AB | NULL | Not 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): no | United States;Serbia;Spain;Austria;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Denmark;Bulgaria;Netherlands;Germany;China;Sweden |