75. クッシング病 Cushing disease Clinical trials / Disease details
臨床試験数 : 203 / 薬物数 : 191 - (DrugBank : 51) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 128
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2013-000267-84-BG (EUCTR) | 12/12/2017 | 18/09/2017 | Study 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 4 | Portugal;United States;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of | ||
| 2 | EUCTR2013-000267-84-PT (EUCTR) | 24/04/2017 | 22/02/2017 | Study 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Thailand;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of | ||
| 3 | EUCTR2013-000267-84-PL (EUCTR) | 05/02/2016 | 16/12/2015 | Study 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 - Roll over protocol with pasireotide | Cushing's diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAF MedDRA version: 21.0;Level: LLT;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864 MedDRA version: 20.0;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 MedDRA version: 20.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Not possible to specify | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Portugal;United States;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of | ||
| 4 | EUCTR2012-002916-16-PL (EUCTR) | 29/06/2015 | 16/03/2015 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 133 | Phase 4 | United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China | ||
| 5 | EUCTR2012-002916-16-BE (EUCTR) | 04/05/2015 | 31/03/2015 | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 4 | United States;Spain;Thailand;Turkey;Russian Federation;India;Poland;Belgium;Brazil;Romania;Denmark;Peru;Bulgaria;Germany;Netherlands;China | ||
| 6 | EUCTR2013-002170-49-NL (EUCTR) | 25/03/2015 | 17/12/2014 | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease | Cushing's disease MedDRA version: 18.1;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 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: Dostinex Product Name: Cabergoline INN or Proposed INN: cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 64 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands | ||
| 7 | EUCTR2013-000267-84-ES (EUCTR) | 11/03/2015 | 03/03/2015 | Study 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 - Roll over protocol with pasireotide | Cushing's disease Acromegaly Neuroendocrine tumors Pituitary tumors EctopicACTH secreting (EAS) tumors Dumping Syndrome Prostate cancer Melanomanegative for bRAF;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Taiwan;Greece;Spain;Thailand;Russian Federation;Israel;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;China;Korea, Republic of | |||
| 8 | EUCTR2012-002916-16-DE (EUCTR) | 19/08/2014 | 17/03/2014 | 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 AG | NULL | Not 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): yes | United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China | ||
| 9 | EUCTR2012-002916-16-DK (EUCTR) | 01/07/2014 | 09/04/2014 | Study of management of pasireotide-induced hyperglycemiain adult patients with Cushing’s disease or acromegaly | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 133 | Phase 4 | United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China | ||
| 10 | EUCTR2013-002170-49-BE (EUCTR) | 19/03/2014 | 04/12/2013 | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline 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 | Trade Name: Signifor Product Name: pasireotide 0.3mg Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide 0.6mg Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Signifor Product Name: pasireotide 0.9 mg Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: Dostinex Product Name: Cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 64 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 11 | EUCTR2013-002170-49-HU (EUCTR) | 03/02/2014 | 13/12/2013 | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease | Cushing's disease MedDRA version: 18.0;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 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: Dostinex Product Name: Cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 12 | EUCTR2013-002170-49-IT (EUCTR) | 21/01/2014 | 22/10/2013 | Study of the efficacy and safety of pasireotide s.c. +/- cabergoline in patients with Cushing’s disease | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease | Cushing's 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] | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: NA Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: NA Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: NA Trade Name: Dostinex Product Name: Cabergoline Product Code: NA INN or Proposed INN: cabergoline Other descriptive name: NA | NOVARTIS FARMA S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany | ||
| 13 | EUCTR2013-002170-49-ES (EUCTR) | 21/11/2013 | 12/11/2013 | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s disease | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: SIGNIFOR Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: PASIREOTIDE DIASPARTATE Trade Name: SIGNIFOR Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: PASIREOTIDE DIASPARTATE Trade Name: SIGNIFOR Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Other descriptive name: PASIREOTIDE DIASPARTATE Trade Name: Dostinex Product Name: Cabergoline INN or Proposed INN: CABERGOLINE Other descriptive name: CABERGOLINE | Novartis Farmacéutica , S.A. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 14 | EUCTR2013-002170-49-DE (EUCTR) | 19/11/2013 | 17/09/2013 | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease | A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline 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] - 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: Dostinex Product Name: Cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany | ||
| 15 | EUCTR2013-000267-84-FR (EUCTR) | 07/08/2013 | 23/09/2015 | 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 | 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 diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAF | Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Greece;Spain;Thailand;Russian Federation;Israel;Italy;France;Mexico;Canada;Belgium;Brazil;Australia;Germany;Norway;China | |||
| 16 | EUCTR2013-000267-84-IT (EUCTR) | 07/06/2013 | 08/04/2013 | Protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide 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 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 FARMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Mexico;Canada;Belgium;Brazil;Thailand;Australia;Israel;Russian Federation;China;Italy | |||
| 17 | EUCTR2013-000267-84-BE (EUCTR) | 05/06/2013 | 22/04/2013 | Study 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 diseaseAcromegalyCarcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanomaMetastatic Merkel cell carcinoma;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 Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE Trade Name: Signifor Product Name: pasireotide Product Code: SOM230 | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;United States;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;China | ||
| 18 | EUCTR2009-011128-70-NL (EUCTR) | 18/11/2011 | 10/08/2011 | A phase 3 studie to evaluate if pasireotide is safe and works in patients with Cushing’s disease | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Netherlands;Germany;China;Japan | ||
| 19 | EUCTR2009-011128-70-BE (EUCTR) | 25/10/2011 | 07/09/2011 | A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;China;Japan | ||
| 20 | EUCTR2009-011128-70-PL (EUCTR) | 12/10/2011 | 14/09/2011 | phase III study to evaluate safety and efficacy of pasireotide LAR in patients with Cushing's disease | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Belgium;Poland;Brazil;Peru;Germany;China;Japan | ||
| 21 | EUCTR2010-024165-44-CZ (EUCTR) | 02/09/2011 | 18/07/2011 | safety and efficacy of pasireotide s.c. in patients with Cushing's disease | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | Cushing’s disease MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Signifor Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE INN or Proposed INN: PASIREOTIDE DIASPARTATE INN or Proposed INN: PASIREOTIDE DIASPARTATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United States;Czech Republic;Greece;Brazil;Thailand;Spain;Romania;Russian Federation;Netherlands;Germany;Korea, Republic of | |||
| 22 | EUCTR2010-024165-44-DE (EUCTR) | 05/08/2011 | 12/05/2011 | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape | Cushing’s disease MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Signifor Product Name: Signifor Product Code: SOM230 300µg INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: Signifor Product Code: SOM230 600µg INN or Proposed INN: pasireotide Trade Name: Signifor Product Name: Signifor Product Code: SOM230 900µg INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Czech Republic;Greece;Spain;Netherlands;Germany |