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 | NCT04569591 (ClinicalTrials.gov) | March 22, 2023 | 29/9/2020 | Corticotrophin-releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing s Disease | Corticotrophin-Releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's Disease | Cushing's Disease;Pituitary Adenoma | Drug: Acthrel | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Not yet recruiting | 8 Years | N/A | All | 22 | N/A | United States |
| 2 | NCT04339751 (ClinicalTrials.gov) | March 22, 2023 | 8/4/2020 | Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing s Disease | The Effect of Vorinostat on ACTH Producing Pituitary Adenomas in Cushing's Disease | Cushing's Disease | Drug: Vorinostat | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Recruiting | 18 Years | N/A | All | 22 | Phase 2 | United States |
| 3 | EUCTR2021-006184-19-BG (EUCTR) | 22/06/2022 | 31/05/2022 | Study of SPI-62 in Patients with Adrenocorticotropic Hormone-dependent Cushing’s Syndrome | SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing’s Syndrome | Cushing’s Syndrome MedDRA version: 20.1;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: SPI-62 Product Code: SPI-62 INN or Proposed INN: Not applicable Other descriptive name: 11-ß-hydroxysteroid dehydrogenase type 1 | Sparrow Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | United States;Romania;Bulgaria | ||
| 4 | NCT05307328 (ClinicalTrials.gov) | March 1, 2022 | 23/3/2022 | SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome | SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome | Cushing's Syndrome I;Cushing Disease Due to Increased ACTH Secretion;Cortisol Excess;Cortisol; Hypersecretion;Cortisol Overproduction;Ectopic ACTH Secretion | Drug: SPI-62;Drug: Placebo | Sparrow Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 26 | Phase 2 | Romania;Bulgaria;United States |
| 5 | EUCTR2019-004019-29-IT (EUCTR) | 15/07/2021 | 07/10/2020 | Italian study to evaluate the efficacy of retinoic acid and cabergoline therapy in combination in Cushing's disease. | Medical combination therapy with retinoic acid and cabergoline in ACTH-secreting pituitary adenoma: a prospective and randomized study. - CRACCA | Cushing's disease in patients in whom pituitary surgery has not been curative or in situations where it is contraindicated or refused by patient. MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Dostinex Product Name: Cabergolina Product Code: [G02CB03] INN or Proposed INN: CABERGOLINA Other descriptive name: NON COMMERCIAL Trade Name: VESANOID Product Name: Tretinoina Product Code: [L01XX14] INN or Proposed INN: TRETINOINA Other descriptive name: NON COMMERCIAL | Dipartimento di Medicina-DIMED, università di Padova | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Italy | ||
| 6 | ChiCTR-OPC-17011664 | 2017-08-01 | 2017-06-14 | A single center clinical study of EGFR/HER2 targeted inhibitor Lapatinib in the treatment of refractory Cushing's disease | A single center clinical study of EGFR/HER2 targeted inhibitor Lapatinib in the treatment of refractory Cushing's disease | Pituitary ACTH-secreting adenoma | Treatment group:lapatinib; | Peking Union Medical College Hospital | NULL | Pending | 18 | 75 | Both | Treatment group:30; | China | |
| 7 | 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 | ||
| 8 | NCT02468193 (ClinicalTrials.gov) | September 24, 2015 | 8/6/2015 | Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome | A Phase II, Open-label, Dose Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of Osilodrostat in Patients With All Types of Endogenous Cushing's Syndrome Except Cushing's Disease | Cushing's Syndrome;Ectopic Corticotropin Syndrome;Adrenal Adenoma;Adrenal Carcinoma;AIMAH;PPNAD | Drug: Osilodrostat | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 85 Years | All | 9 | Phase 2 | Japan |
| 9 | EUCTR2013-002063-26-IT (EUCTR) | 08/09/2013 | 23/07/2013 | A trial with Metyrapone in Cushing's syndrome | A prospective open-label Phase 2 study of METYRAPONE as a preoperative treatment in patients with ACTH-independent Cushing’s syndrome due to adrenal adenoma. - METYX01 | Cushing's syndrome;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Matyrapone Product Name: Metyrapone Product Code: Metyrapone | S.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi Orbassano | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2 | Italy | ||
| 10 | 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 | |||
| 11 | NCT01794793 (ClinicalTrials.gov) | June 10, 2013 | 15/2/2013 | Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies | An Open Label, Multi-center 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 Disease;Acromegaly;Neuroendocrine Tumors;Pituitary Tumors;Ectopic ACTH Secreting (EAS) Tumors;Dumping Syndrome;Prostate Cancer;Melanoma Negative for bRAF;Melanoma Negative for nRAS | Drug: Pasireotide;Drug: Cabergoline | RECORDATI GROUP | NULL | Active, not recruiting | 18 Years | N/A | All | 413 | Phase 4 | Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Taiwan;Thailand;Turkey;United States;China |
| 12 | EUCTR2011-003264-77-NL (EUCTR) | 31/10/2011 | 07/09/2011 | A study with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease. | A prospective trial with ketoconazole and octreotide combination therapy for treatment of Cushing’s disease. - Octreotide and ketoconazole for Cushing's disease | Cushing's disease (which is caused by an ACTH producing pituitary adenoma) 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] | Trade Name: Octreotide Product Name: Octreotide Product Code: RVG 18236 Trade Name: Ketoconazole Product Name: Ketoconazole Product Code: RVG 08938 Trade Name: Cabergoline Product Name: Cabergoline Product Code: RVG 15375 | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 13 | NCT01459237 (ClinicalTrials.gov) | October 11, 2011 | 21/10/2011 | Effects of Hormone Stimulation on Brain Scans for Cushing s Disease | Prospective Evaluation of the Effect of Corticotropin-Releasing Hormone Stimulation on 18F-Fludeoxyglucose High-Resolution Positron-Emission Tomography in Cushing's Disease | Pituitary Neoplasm | Drug: Acthrel | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 8 Years | N/A | All | 30 | Early Phase 1 | United States |
| 14 | EUCTR2010-018720-12-SE (EUCTR) | 22/04/2010 | 18/02/2010 | Behandling med kabergolin hos patienter med ACTH-beroende Cushing´s syndrom(treatment with cabergoline in patients with ACTH-dependent Cushing´s syndrome - Cushing and cabergoline | Behandling med kabergolin hos patienter med ACTH-beroende Cushing´s syndrom(treatment with cabergoline in patients with ACTH-dependent Cushing´s syndrome - Cushing and cabergoline | A) Men and women aged 18 to 75 years with hypercortisolism due to ACTH-dependent Cushing's syndrome will be treated in the period between diagnosis and planned surgery or radiation therapy.B) Men and women aged 18 to 75 years due to ACTH-dependent Cushing's syndrome who have persistent hypercortisolism post-surgery or post-radiotherapy. | Product Name: cabergoline | Swedish Pituitary Study group | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Sweden | |||
| 15 | 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 | |||
| 16 | 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 | ||
| 17 | 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 | |||
| 18 | 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 | |||
| 19 | NCT00422201 (ClinicalTrials.gov) | May 15, 2007 | 12/1/2007 | Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion | Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion | Cushing's Syndrome | Drug: Mifepristone | HRA Pharma | NULL | Terminated | 18 Years | 85 Years | All | 18 | Phase 2 | United States;France;Germany;Italy;Netherlands;United Kingdom |
| 20 | 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 | |||
| 21 | 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 | ||||
| 22 | EUCTR2006-004679-36-DE (EUCTR) | 05/04/2007 | 09/10/2006 | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. MedDRA version: 14.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.0;Classification code 10014146;Term: Ectopic ACTH syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Code: HRA052015 INN or Proposed INN: mifepristone Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 35 | France;United States;Netherlands;Germany;Italy | |||
| 23 | EUCTR2006-004111-22-DE (EUCTR) | 04/04/2007 | 18/04/2007 | 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: SOM230 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: SOM230 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: SOM230 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;France;Hungary;Greece;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 24 | NCT00612066 (ClinicalTrials.gov) | April 2007 | 8/2/2008 | Rosiglitazone in Treating Patients With Newly Diagnosed ACTH-Secreting Pituitary Tumor (Cushing Disease) | An Open Label, Multicenter Study Evaluating the Safety and Efficacy of Short Term (6 Weeks) Rosiglitazone Treatment in Patient's With Cushing's Disease | Cushing's Disease | Drug: rosiglitazone maleate | Jonsson Comprehensive Cancer Center | National Institutes of Health (NIH) | Terminated | 18 Years | 65 Years | All | 2 | Phase 2 | United States |
| 25 | 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 | |||
| 26 | EUCTR2006-004679-36-NL (EUCTR) | 22/03/2007 | 31/01/2007 | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. MedDRA version: 8.1;Level: LLT;Classification code 10014155;Term: Ectopic corticotrophin syndrome | Product Code: HRA052015 INN or Proposed INN: mifepristone Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 22 | Germany;Netherlands;France;Italy | |||
| 27 | 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 | ||
| 28 | 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 | |||
| 29 | EUCTR2006-004679-36-IT (EUCTR) | 15/01/2007 | 30/01/2007 | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing s syndrome caused by ectopic Adrenal Corticotrophin Hormone ACTH secretion - HRA052015 in EAS | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing s syndrome caused by ectopic Adrenal Corticotrophin Hormone ACTH secretion - HRA052015 in EAS | Cushing s Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone ACTH Secretion MedDRA version: 9.1;Level: LLT;Classification code 10014146;Term: Ectopic ACTH syndrome | Product Name: Mifepristone Product Code: HRA052015 | LABORATOIRE HRA PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 22 | Germany;Netherlands;France;Italy | |||
| 30 | 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 | |||
| 31 | EUCTR2006-004679-36-FR (EUCTR) | 13/12/2006 | 29/09/2006 | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. - HRA052015 in EAS | Treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion. MedDRA version: 8.1;Level: LLT;Classification code 10014155;Term: Ectopic corticotrophin syndrome | Product Code: HRA052015 INN or Proposed INN: mifepristone Other descriptive name: 17ß-hydroxy-11ß-(4-dimethylaminophenyl)17a-(prop-1-ynyl)estra-4,9-dien-3-one | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 22 | France;Netherlands;Germany;Italy | |||
| 32 | 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 | |||
| 33 | NCT00001180 (ClinicalTrials.gov) | March 1982 | 3/11/1999 | Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency | Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency | Adrenal Gland Hyperfunction;Adrenal Gland Hypofunction;Cushing's Syndrome;Healthy | Drug: Ovine Corticotropin-Releasing Hormone (oCRH) | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Completed | N/A | N/A | Both | 2250 | N/A | United States |