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

  
15 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
1EUCTR2012-002916-16-DK
(EUCTR)
01/07/201409/04/2014Study of management of pasireotide-induced hyperglycemiain adult patients with Cushing’s disease or acromegalyA multi-center, randomized, open-label, Phase IV study toinvestigate the management of pasireotide-inducedhyperglycemia with incretin based therapy or insulin inadult patients with Cushing’s disease or acromegaly. Cushing's disease and acromegaly
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: SOM230B
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Other descriptive name: PASIREOTIDE PAMOATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Other descriptive name: PASIREOTIDE PAMOATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
133Phase 4United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China
2EUCTR2010-024165-44-ES
(EUCTR)
22/08/201107/07/2011Estudio en el que se sabe qué fármaco toma cada paciente, llevado a cabo en varios hospitales, con Pasireotida subcutánea en pacientes con enfermedad de CushingEstudio abierto, multicéntrico, de acceso expandido de pasireotida s.c., en pacientes con enfermedad de Cushing Enfermedad de Cushing
MedDRA version: 14.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Pasireotida 300
Product Code: SOM230
INN or Proposed INN: Pasireotida
Product Name: Pasireotida 600
Product Code: SOM230B
INN or Proposed INN: Pasireotida 600
Other descriptive name: SOM230B
Product Name: Pasireotida 900
Product Code: SOM230B
INN or Proposed INN: Pasireotida 900
Other descriptive name: SOM230B
Product Name: Pasireotida 300
Product Code: SOM230
INN or Proposed INN: Pasireotida
Product Name: Pasireotida 600
Product Code: SOM230B
INN or Proposed INN: Pasireotida 600
Other descriptive name: SOM230B
Product Name: Pasireotida 900
Product Code: SOM230B
INN or Proposed INN: Pasireotida 900
Other descriptive name: SOM230B
Product Name: Pasireotida 300
Product Code: SOM230
INN or Proposed INN: Pasireotida
Product Name: Pasireotida 600
Product Code: SOM230B
INN or Proposed INN: Pasireotida 600
Other descriptive name: SOM230B
Product Name: Pasireotida 900
Product Code: SOM230B
INN or Proposed INN: Pasireotida 900
Other descriptive name: SOM230B
NOVARTIS FARMACEUTICA S.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Egypt;Hungary;Czech Republic;Greece;Argentina;Brazil;Thailand;Spain;Romania;Netherlands;Germany;Korea, Republic of
3EUCTR2006-004111-22-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
4EUCTR2006-004111-22-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
5EUCTR2006-004111-22-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
6EUCTR2006-004111-22-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
7EUCTR2006-004111-22-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
8EUCTR2006-004080-55-NL
(EUCTR)
26/04/200719/01/2007Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's DiseaseStepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's Disease The medical condition to be investigated is Cushing's disease which is caused by an ACTH producing pituitary adenoma
MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease
Product Name: SOM230
Product Code: SOM230B
INN or Proposed INN: pasireotide
Trade Name: Dostinex
Product Name: Dostinex
INN or Proposed INN: CABERGOLINE
Trade Name: Nizoral
Product Name: Ketoconazole
INN or Proposed INN: KETOCONAZOLE
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
9EUCTR2006-004111-22-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
10EUCTR2006-004111-22-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
11EUCTR2006-004111-22-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
12EUCTR2006-004111-22-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
13EUCTR2006-004111-22-IT
(EUCTR)
23/11/200605/01/2007//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 de novo or persistent/recurrent Cushing disease
MedDRA version: 14.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230B
INN or Proposed INN: pasireotide
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
100Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
14EUCTR2004-002407-32-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
15EUCTR2004-002407-32-IT
(EUCTR)
21/10/200416/09/2004\\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 Treatment of Cushing's disease
MedDRA version: 14.1;Level: PT;Classification code 10035109;Term: Pituitary-dependent Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: NA
Product Code: SOM230B
INN or Proposed INN: PASIREOTIDE
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
26United Kingdom;Italy