Trp ( 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11

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
1EUCTR2006-004111-22-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
2EUCTR2006-004111-22-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
3EUCTR2006-004111-22-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
4EUCTR2006-004111-22-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
5EUCTR2006-004111-22-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
6EUCTR2006-004111-22-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
7EUCTR2006-004111-22-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
8EUCTR2006-004111-22-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
9EUCTR2006-004111-22-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
10EUCTR2006-004111-22-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
11EUCTR2004-002407-32-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