Phe ( 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33

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
1EUCTR2017-001219-35-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 ABNULLNot RecruitingFemale: yes
Male: yes
54Phase 3France;United States;Hungary;Greece;Spain;Poland;Romania;Denmark;Bulgaria;Israel;Netherlands;Italy
2EUCTR2017-001219-35-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
3EUCTR2017-001219-35-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
4EUCTR2017-001219-35-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
5EUCTR2017-001219-35-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
6EUCTR2017-001219-35-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
7EUCTR2017-001219-35-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 ABNULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands
8EUCTR2017-001219-35-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
9EUCTR2017-001219-35-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
10EUCTR2016-003060-40-GB
(EUCTR)
17/01/201722/12/2016Treating side effects of steroid medicationTargeting 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 GovernanceNULLNot RecruitingFemale: no
Male: yes
32Phase 2United Kingdom
11EUCTR2013-002133-37-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
12EUCTR2013-002133-37-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
13EUCTR2013-002133-37-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
14EUCTR2013-002133-37-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
15EUCTR2013-002133-37-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
16EUCTR2013-002133-37-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
17EUCTR2013-002133-37-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
18EUCTR2013-002133-37-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
19EUCTR2013-002133-37-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
20EUCTR2013-002133-37-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
21EUCTR2013-002133-37-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
22EUCTR2006-004111-22-HU
(EUCTR)
29/10/200822/07/2008A 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 diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
146Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy
23EUCTR2006-004111-22-GB
(EUCTR)
19/03/200820/03/2008A 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 diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
146Phase 3Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;Italy;United Kingdom
24EUCTR2006-004111-22-GR
(EUCTR)
11/12/200730/07/2007A 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 diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
146Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
25EUCTR2006-004111-22-PT
(EUCTR)
09/11/200727/06/2007A 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 diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy
26EUCTR2006-004111-22-FI
(EUCTR)
04/05/200724/01/2007A 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 diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy
27EUCTR2006-004111-22-DE
(EUCTR)
04/04/200718/04/2007A 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 diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
28EUCTR2006-004111-22-FR
(EUCTR)
23/03/200712/02/2007A 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 diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
100Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
29EUCTR2006-004111-22-BE
(EUCTR)
06/03/200714/11/2006A 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 diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
146Phase 3Denmark;Germany;United Kingdom;Italy;Portugal;France;Hungary;Greece;Finland;Spain;Belgium
30EUCTR2006-004111-22-ES
(EUCTR)
05/02/200711/08/2014A 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 diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
162Portugal;United States;Greece;Finland;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China
31EUCTR2006-004111-22-DK
(EUCTR)
05/01/200710/11/2006A 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 diseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
146Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy
32EUCTR2004-002407-32-GB
(EUCTR)
13/01/200527/06/2005Extension 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 diseaseExtension 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 womenProduct Code: SOM230B
INN or Proposed INN: Pasireotide
Other descriptive name: Cyclo(diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe)
Novartis Pharmaceuticals UK LtdNULLNot RecruitingFemale: yes
Male: yes
26Italy;United Kingdom
33NCT00001452
(ClinicalTrials.gov)
December 14, 19953/11/1999Defining the Genetic Basis for the Development of Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the Carney ComplexDefinition of the Genotype and Clinical Phenotype of Primary Pigmented Nodular Adrenocortical Disease (PPNAD), Carney Complex, Peutz-Jeghers Syndrome and Related ConditionsCushing's Syndrome;Pituitary Adenoma;Carney Complex;Primary Pigmented Nodular Adrenocortical Disease;Peutz-Jeghers SyndromeDrug: oCRHEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLCompleted3 Years70 YearsAll1387United States