75. クッシング病 Cushing disease Clinical trials / Disease details
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 | EUCTR2017-001219-35-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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | EUCTR2016-003060-40-GB (EUCTR) | 17/01/2017 | 22/12/2016 | Treating side effects of steroid medication | Targeting 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 Governance | NULL | Not Recruiting | Female: no Male: yes | 32 | Phase 2 | United Kingdom | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | EUCTR2006-004111-22-HU (EUCTR) | 29/10/2008 | 22/07/2008 | 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 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 23 | EUCTR2006-004111-22-GB (EUCTR) | 19/03/2008 | 20/03/2008 | 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 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Phase 3 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;Italy;United Kingdom | ||
| 24 | EUCTR2006-004111-22-GR (EUCTR) | 11/12/2007 | 30/07/2007 | 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 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 25 | EUCTR2006-004111-22-PT (EUCTR) | 09/11/2007 | 27/06/2007 | 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 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy | |||
| 26 | EUCTR2006-004111-22-FI (EUCTR) | 04/05/2007 | 24/01/2007 | 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 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy | |||
| 27 | EUCTR2006-004111-22-DE (EUCTR) | 04/04/2007 | 18/04/2007 | 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 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 28 | EUCTR2006-004111-22-FR (EUCTR) | 23/03/2007 | 12/02/2007 | 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 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 29 | EUCTR2006-004111-22-BE (EUCTR) | 06/03/2007 | 14/11/2006 | 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 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Phase 3 | Denmark;Germany;United Kingdom;Italy;Portugal;France;Hungary;Greece;Finland;Spain;Belgium | ||
| 30 | EUCTR2006-004111-22-ES (EUCTR) | 05/02/2007 | 11/08/2014 | 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 | 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 | 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. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Portugal;United States;Greece;Finland;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China | |||
| 31 | EUCTR2006-004111-22-DK (EUCTR) | 05/01/2007 | 10/11/2006 | 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 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 32 | EUCTR2004-002407-32-GB (EUCTR) | 13/01/2005 | 27/06/2005 | 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 | 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 | 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 women | Product Code: SOM230B INN or Proposed INN: Pasireotide Other descriptive name: Cyclo(diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) | Novartis Pharmaceuticals UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 26 | Italy;United Kingdom | |||
| 33 | NCT00001452 (ClinicalTrials.gov) | December 14, 1995 | 3/11/1999 | Defining the Genetic Basis for the Development of Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the Carney Complex | Definition of the Genotype and Clinical Phenotype of Primary Pigmented Nodular Adrenocortical Disease (PPNAD), Carney Complex, Peutz-Jeghers Syndrome and Related Conditions | Cushing's Syndrome;Pituitary Adenoma;Carney Complex;Primary Pigmented Nodular Adrenocortical Disease;Peutz-Jeghers Syndrome | Drug: oCRH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Completed | 3 Years | 70 Years | All | 1387 | United States |