Pasireotide 20mg ( 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2

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
1EUCTR2013-000267-84-BG
(EUCTR)
12/12/201718/09/2017Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An 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 diseaseAcromegaly Carcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanoma Metastatic Merkel cell carcinoma;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: Signifor
Product Name: pasireotide 20mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 40mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 60mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 4Portugal;United States;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of
2EUCTR2013-000267-84-PT
(EUCTR)
24/04/201722/02/2017Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An 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 diseaseAcromegaly Carcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanoma Metastatic Merkel cell carcinoma
MedDRA version: 20.0;Level: PT;Classification code 10000599;Term: Acromegaly;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 21.0;Level: LLT;Classification code 10007271;Term: Carcinoid tumor;System Organ Class: 100000004864
MedDRA version: 21.0;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864
MedDRA version: 20.0;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10027481;Term: Metastatic melanoma;System Organ Class: 100000004864
MedDRA version: 20.1;Classification code 10013810;Term: Dumping syndrome;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 21.1;Classification code 10064025;Term: Merkel cell carcinoma;System Organ Class: 100000004864;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide 20mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 40mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 60mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Recordati AGNULLNot RecruitingFemale: yes
Male: yes
220Phase 4Portugal;United States;Taiwan;Greece;Spain;Thailand;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of