PASIREOTIDE PAMOATE ( DrugBank: Pasireotide )


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9

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
1EUCTR2012-002916-16-PL
(EUCTR)
29/06/201516/03/2015Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegalyA multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult 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
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: pasireotide pamoate
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE PAMOATE
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE PAMOATE
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
133Phase 4United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China
2EUCTR2012-002916-16-BE
(EUCTR)
04/05/201531/03/2015Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegalyA multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. Cushing's disease and acromegaly
MedDRA version: 17.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 17.1;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
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
132Phase 4United States;Spain;Thailand;Turkey;Russian Federation;India;Poland;Belgium;Brazil;Romania;Denmark;Peru;Bulgaria;Germany;Netherlands;China
3EUCTR2012-002916-16-DE
(EUCTR)
19/08/201417/03/2014 Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult 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, 300micrograms
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 600 micrograms
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 900 micrograms
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE DIASPARTATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR, 20 mg
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
133 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China
4EUCTR2012-002916-16-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
5EUCTR2013-000267-84-IT
(EUCTR)
07/06/201308/04/2013Protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatmentAn open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing’s diseaseNeuroendocrine tumors
MedDRA version: 14.1;Level: LLT;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864
MedDRA version: 14.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
NOVARTIS FARMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Mexico;Canada;Belgium;Brazil;Thailand;Australia;Israel;Russian Federation;China;Italy
6EUCTR2009-011128-70-NL
(EUCTR)
18/11/201110/08/2011A phase 3 studie to evaluate if pasireotide is safe and works in patients with Cushing’s diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease Cushing's disease
MedDRA version: 16.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;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
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
148Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Netherlands;Germany;China;Japan
7EUCTR2009-011128-70-BE
(EUCTR)
25/10/201107/09/2011A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease Cushing's disease
MedDRA version: 19.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;China;Japan
8EUCTR2009-011128-70-PL
(EUCTR)
12/10/201114/09/2011phase III study to evaluate safety and efficacy of pasireotide LAR in patients with Cushing's diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease - Cushing's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Belgium;Poland;Brazil;Peru;Germany;China;Japan
9EUCTR2009-011128-70-DE
(EUCTR)
04/10/201122/07/2011phase III study to evaluate safety and efficacy of pasireotide LAR in patients with Cushing's diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease Cushing's disease
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Peru;Germany;China;Japan