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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | NCT02060383 (ClinicalTrials.gov) | May 23, 2014 | 10/2/2014 | 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;Acromegaly | Drug: Pasireotide s.c.;Drug: Sitagliptin;Drug: Liraglutide;Drug: Insulin;Drug: Pasireotide LAR;Drug: Metformin | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 249 | Phase 4 | United States;Belgium;Brazil;China;Denmark;Germany;India;Peru;Poland;Russian Federation;Thailand;Turkey |
| 6 | 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 | ||
| 7 | NCT01374906 (ClinicalTrials.gov) | November 4, 2011 | 14/6/2011 | Efficacy and Safety of Pasireotide Administered Monthly 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 | Drug: pasireotide LAR;Drug: SOM230 LAR 30 mg;Drug: SOM230 LAR 10 mg | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 150 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;China;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Russian Federation;Spain;Thailand;Turkey;United Kingdom |
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | EUCTR2009-011128-70-IT (EUCTR) | 10/10/2011 | 28/02/2012 | A 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: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | 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: NA | NOVARTIS FARMA | 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 | ||
| 11 | EUCTR2009-011128-70-DE (EUCTR) | 04/10/2011 | 22/07/2011 | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Peru;Germany;China;Japan | ||
| 12 | EUCTR2009-011128-70-GB (EUCTR) | 24/08/2011 | 15/07/2011 | A randomized, double-blind, multicentre, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease | A randomized, double-blind, multicentre, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease | Cushing's disease MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 | Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide Other descriptive name: PASIREOTIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 162 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;Netherlands;China;Japan |