75. クッシング病 Cushing disease Clinical trials / Disease details
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. | 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-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 | ||
| 2 | EUCTR2010-024165-44-ES (EUCTR) | 22/08/2011 | 07/07/2011 | Estudio en el que se sabe qué fármaco toma cada paciente, llevado a cabo en varios hospitales, con Pasireotida subcutánea en pacientes con enfermedad de Cushing | Estudio abierto, multicéntrico, de acceso expandido de pasireotida s.c., en pacientes con enfermedad de Cushing | Enfermedad de Cushing MedDRA version: 14.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Pasireotida 300 Product Code: SOM230 INN or Proposed INN: Pasireotida Product Name: Pasireotida 600 Product Code: SOM230B INN or Proposed INN: Pasireotida 600 Other descriptive name: SOM230B Product Name: Pasireotida 900 Product Code: SOM230B INN or Proposed INN: Pasireotida 900 Other descriptive name: SOM230B Product Name: Pasireotida 300 Product Code: SOM230 INN or Proposed INN: Pasireotida Product Name: Pasireotida 600 Product Code: SOM230B INN or Proposed INN: Pasireotida 600 Other descriptive name: SOM230B Product Name: Pasireotida 900 Product Code: SOM230B INN or Proposed INN: Pasireotida 900 Other descriptive name: SOM230B Product Name: Pasireotida 300 Product Code: SOM230 INN or Proposed INN: Pasireotida Product Name: Pasireotida 600 Product Code: SOM230B INN or Proposed INN: Pasireotida 600 Other descriptive name: SOM230B Product Name: Pasireotida 900 Product Code: SOM230B INN or Proposed INN: Pasireotida 900 Other descriptive name: SOM230B | NOVARTIS FARMACEUTICA S.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Egypt;Hungary;Czech Republic;Greece;Argentina;Brazil;Thailand;Spain;Romania;Netherlands;Germany;Korea, Republic of | ||
| 3 | EUCTR2006-004111-22-HU (EUCTR) | 29/10/2008 | 22/07/2008 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 4 | EUCTR2006-004111-22-GB (EUCTR) | 19/03/2008 | 20/03/2008 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Phase 3 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2006-004111-22-GR (EUCTR) | 11/12/2007 | 30/07/2007 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 6 | EUCTR2006-004111-22-PT (EUCTR) | 09/11/2007 | 27/06/2007 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy | |||
| 7 | EUCTR2006-004111-22-FI (EUCTR) | 04/05/2007 | 24/01/2007 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;Hungary;Greece;Finland;Denmark;Germany;United Kingdom;Italy | |||
| 8 | EUCTR2006-004080-55-NL (EUCTR) | 26/04/2007 | 19/01/2007 | Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's Disease | Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole - Stepwise Medical Treatment of Cushing's Disease | The medical condition to be investigated is Cushing's disease which is caused by an ACTH producing pituitary adenoma MedDRA version: 8.1;Level: LLT;Classification code 10011651;Term: Cushing's disease | Product Name: SOM230 Product Code: SOM230B INN or Proposed INN: pasireotide Trade Name: Dostinex Product Name: Dostinex INN or Proposed INN: CABERGOLINE Trade Name: Nizoral Product Name: Ketoconazole INN or Proposed INN: KETOCONAZOLE | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 9 | EUCTR2006-004111-22-FR (EUCTR) | 23/03/2007 | 12/02/2007 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 10 | EUCTR2006-004111-22-BE (EUCTR) | 06/03/2007 | 14/11/2006 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Phase 3 | Denmark;Germany;United Kingdom;Italy;Portugal;France;Hungary;Greece;Finland;Spain;Belgium | ||
| 11 | EUCTR2006-004111-22-ES (EUCTR) | 05/02/2007 | 11/08/2014 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Portugal;United States;Greece;Finland;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China | |||
| 12 | EUCTR2006-004111-22-DK (EUCTR) | 05/01/2007 | 10/11/2006 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | Portugal;Hungary;Greece;Finland;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 13 | EUCTR2006-004111-22-IT (EUCTR) | 23/11/2006 | 05/01/2007 | // | A 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 | de novo or persistent/recurrent Cushing 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] | Product Name: pasireotide Product Code: SOM230B INN or Proposed INN: pasireotide Product Name: pasireotide Product Code: SOM230B INN or Proposed INN: pasireotide Product Name: pasireotide Product Code: SOM230B INN or Proposed INN: pasireotide | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Portugal;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 14 | EUCTR2004-002407-32-GB (EUCTR) | 13/01/2005 | 27/06/2005 | Extension 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 | Extension 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 women | Product Code: SOM230B INN or Proposed INN: Pasireotide Other descriptive name: Cyclo(diaminoethyl-carbamate)HyPro-Phg-(D)Trp-Lys-Tyr(Bzl)-Phe) | Novartis Pharmaceuticals UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 26 | Italy;United Kingdom | |||
| 15 | EUCTR2004-002407-32-IT (EUCTR) | 21/10/2004 | 16/09/2004 | \\ | Extension 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 | Treatment of Cushing's disease MedDRA version: 14.1;Level: PT;Classification code 10035109;Term: Pituitary-dependent Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: NA Product Code: SOM230B INN or Proposed INN: PASIREOTIDE | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 26 | United Kingdom;Italy |