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 | NCT04339751 (ClinicalTrials.gov) | March 24, 2022 | 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 | Not yet recruiting | 18 Years | N/A | All | 22 | Phase 2 | United States |
| 2 | NCT04569591 (ClinicalTrials.gov) | March 24, 2022 | 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 |
| 3 | EUCTR2020-005605-93-IT (EUCTR) | 21/12/2021 | 22/10/2021 | Efficacy and safety of Silycus® in Cushing’s disease: a multicenter, single arm, openlabel, dose titration, proof of concept study (Silycus®-21) | Efficacy and safety of Silycus® in Cushing’s disease: a multicenter, single arm, openlabel, dose titration, proof of concept study (Silycus®-21) - SILYCUS-21 Trial | Cushing's disease MedDRA version: 20.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Silycus Product Code: [na] | ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2 | Italy | ||
| 4 | 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 | ||
| 5 | JPRN-jRCT1021210011 | 10/06/2021 | 10/06/2021 | A diagnosis of pseudo-Cushing's syndrome using dexamethason/CHR and Alprazolam | A diagnosis of pseudo-Cushing's syndrome using dexamethason/CRH and anxiolytic Alprazolam | Pseudo Cushing's Syndrome Glucocorticoid , Stress, dexamethasone suppression test;D003480 | In patients suspected of having Cushing's syndrome or pseudo-Cushing's syndrome, we perform two loading tests, DEX/CRH and alprazolam tests, in order to confirm the differential ability of this test. | Asari Yuko | NULL | Recruiting | Not applicable | Not applicable | Both | 100 | Phase 2 | Japan |
| 6 | EUCTR2018-001616-30-DE (EUCTR) | 22/12/2020 | 16/03/2020 | Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome | Endogenous Cushing Syndrome MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | United States;Hungary;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy | ||
| 7 | NCT04486859 (ClinicalTrials.gov) | December 1, 2020 | 22/7/2020 | Postoperative Thrombosis Prevention in Patients With CD | A Prospective, Multicenter, Randomized Controlled Study of Postoperative Thrombosis Prevention in Patients With Cushing's Disease | Cushing Disease;DVT;Pulmonary Embolism | Drug: LMWH/Rivaroxaban;Device: IPC | Huashan Hospital | Peking Union Medical College Hospital;West China Hospital | Recruiting | 18 Years | 60 Years | All | 252 | N/A | China |
| 8 | NCT03708900 (ClinicalTrials.gov) | October 30, 2020 | 8/10/2018 | Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Disease | A Phase II, Multicenter, Open-label, Non-comparative Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Osilodrostat in Children and Adolescent Patients With Cushing's Disease | Cushing's Disease | Drug: LCI699 | Novartis Pharmaceuticals | NULL | Recruiting | 6 Years | 18 Years | All | 12 | Phase 2 | Belgium;Bulgaria;Italy;Slovenia;United Kingdom |
| 9 | EUCTR2018-001616-30-BG (EUCTR) | 27/03/2020 | 24/02/2020 | Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome | Endogenous Cushing Syndrome MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | United States;Hungary;Canada;Spain;Poland;Romania;Austria;Israel;Bulgaria;Netherlands;Germany;Italy | ||
| 10 | EUCTR2018-001616-30-ES (EUCTR) | 14/02/2020 | 10/01/2020 | Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome | Endogenous Cushing Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;Germany;Netherlands;Bulgaria;Israel;Austria;Romania;Spain;Poland;Canada;Hungary;United States | ||
| 11 | EUCTR2018-001522-25-IT (EUCTR) | 20/01/2020 | 28/04/2020 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy | ||
| 12 | EUCTR2017-002840-34-NL (EUCTR) | 14/11/2019 | 31/07/2019 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | Portugal;United States;Spain;Costa Rica;Thailand;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 13 | EUCTR2018-001522-25-ES (EUCTR) | 02/10/2019 | 26/07/2019 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | United States;Slovenia;Belgium;Spain;Bulgaria;Italy;United Kingdom | ||
| 14 | EUCTR2018-003096-35-DE (EUCTR) | 04/09/2019 | 14/06/2019 | A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo. | Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE | Endogenous Cushing syndrome MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Name: Relacorilant Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 145 | Phase 3 | United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy | ||
| 15 | EUCTR2017-004647-20-NL (EUCTR) | 29/08/2019 | 23/11/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;United States;Hungary;Greece;Poland;Spain;Romania;Israel;Bulgaria;Netherlands;Italy | ||
| 16 | EUCTR2017-002840-34-FR (EUCTR) | 08/07/2019 | 14/06/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan | ||
| 17 | EUCTR2018-003096-35-PL (EUCTR) | 05/07/2019 | 12/04/2019 | A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo. | Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE | Endogenous Cushing syndrome MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Name: Relacorilant Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 145 | Phase 3 | United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy | ||
| 18 | EUCTR2018-001522-25-BG (EUCTR) | 04/07/2019 | 26/03/2019 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy | ||
| 19 | NCT03974789 (ClinicalTrials.gov) | July 1, 2019 | 3/6/2019 | Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms | Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation Study | Cushing Disease | Diagnostic Test: Blood test;Diagnostic Test: 24-hour Urine test;Diagnostic Test: Saliva swab;Diagnostic Test: Dexamethasone test | Centre Hospitalier Universitaire de Nimes | NULL | Recruiting | 18 Years | N/A | All | 380 | Phase 3 | France |
| 20 | EUCTR2018-003096-35-NL (EUCTR) | 19/06/2019 | 11/12/2018 | A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo. | Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - CORT125134-455 | Endogenous Cushing syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Name: Relacorilant Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Germany;Netherlands;Italy | ||
| 21 | EUCTR2017-002840-34-BG (EUCTR) | 18/06/2019 | 07/09/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Portugal;Greece;Thailand;Costa Rica;Spain;Russian Federation;Colombia;Italy;Switzerland;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan | ||
| 22 | EUCTR2018-003096-35-BG (EUCTR) | 05/06/2019 | 28/01/2019 | A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo. | Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE | Endogenous Cushing syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Name: Relacorilant Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 145 | Phase 3 | United States;Canada;Spain;Poland;Romania;Austria;Israel;Bulgaria;Netherlands;Germany;Italy | ||
| 23 | EUCTR2018-001522-25-BE (EUCTR) | 05/06/2019 | 30/04/2019 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy | ||
| 24 | EUCTR2018-003096-35-AT (EUCTR) | 31/05/2019 | 15/02/2019 | A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo. | Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE | Endogenous Cushing syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Name: Relacorilant Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 145 | Phase 3 | United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy | ||
| 25 | EUCTR2018-003096-35-ES (EUCTR) | 23/05/2019 | 12/04/2019 | A study to assess whether a product call relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo. | Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE | Endogenous Cushing syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Name: Relacorilant Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Austria;Israel;Bulgaria;Netherlands;Germany;Italy | ||
| 26 | EUCTR2018-001522-25-SI (EUCTR) | 10/05/2019 | 16/10/2018 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Italy;United Kingdom;Bulgaria;Belgium;Spain;Slovenia;United States | ||
| 27 | NCT04844164 (ClinicalTrials.gov) | April 16, 2019 | 9/4/2021 | Vitamin D Metabolism in Patients With Endocrine Disorders | Prospective Non-randomised Controlled Study of Vitamin D Metabolism in Patients With Endocrine Disorders (Acromegaly, Cushing's Disease, Primary Hyperparathyroidism, Diabetes Mellitus Type 1) Treated With Cholecalciferol Bolus Dose | Pituitary ACTH Hypersecretion;Acromegaly;Diabetes Mellitus, Type 1;Primary Hyperparathyroidism | Drug: Cholecalciferol 15000 UNT/ML Oral Solution | Endocrinology Research Centre, Moscow | Russian Science Foundation | Recruiting | 18 Years | 60 Years | All | 240 | Phase 1 | Russian Federation |
| 28 | EUCTR2017-004647-20-GR (EUCTR) | 21/03/2019 | 19/02/2019 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 29 | EUCTR2018-001522-25-GB (EUCTR) | 19/03/2019 | 27/09/2018 | A study of osilodrostat in children and adolescents with Cushing's disease | A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: OSILODROSTAT | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United States;Slovenia;Spain;Belgium;Bulgaria;Italy;United Kingdom | ||
| 30 | EUCTR2018-003096-35-IT (EUCTR) | 21/02/2019 | 27/01/2021 | A study to assess whether a product called relacorilant works and is safe to use in patients with Cushing Syndrome; some patients will receive relacorilant whilst others receive a placebo. | Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - GRACE | Endogenous Cushing syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Name: Relacorilant Product Code: [CORT125134] INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4- | CORCEPT THERAPEUTICS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 145 | Phase 3 | United States;Canada;Spain;Poland;Romania;Austria;Bulgaria;Israel;Netherlands;Germany;Italy | ||
| 31 | EUCTR2017-004647-20-BG (EUCTR) | 11/02/2019 | 24/10/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;United States;Hungary;Greece;Poland;Spain;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 32 | EUCTR2017-002840-34-BE (EUCTR) | 07/02/2019 | 16/11/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan | ||
| 33 | EUCTR2017-004647-20-ES (EUCTR) | 17/01/2019 | 25/10/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;France;Hungary;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 34 | EUCTR2017-004647-20-IT (EUCTR) | 11/01/2019 | 15/11/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Turkey;Israel;Italy;France;Hungary;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 35 | NCT03621280 (ClinicalTrials.gov) | January 7, 2019 | 18/5/2018 | Open-label Treatment in Cushing's Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome | Cushing Syndrome;Cushing Disease | Drug: Levoketoconazole | Cortendo AB | NULL | Active, not recruiting | 18 Years | N/A | All | 60 | Phase 3 | United States;Bulgaria;France;Greece;Hungary;Israel;Italy;Netherlands;Poland;Romania;Spain;Denmark;Turkey |
| 36 | EUCTR2017-004647-20-HU (EUCTR) | 13/11/2018 | 26/09/2018 | A Study to Assess Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | An Open-label Extension Study of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | Hungary;Poland;Romania;United States;Greece;Spain;Turkey;Israel;Italy;France;Denmark;Bulgaria;Netherlands | ||
| 37 | NCT03774446 (ClinicalTrials.gov) | November 2, 2018 | 6/11/2018 | Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease | A Phase 2 Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease | Cushing Disease | Drug: Seliciclib | Cedars-Sinai Medical Center | NULL | Recruiting | 18 Years | N/A | All | 29 | Phase 2 | United States |
| 38 | EUCTR2017-002840-34-ES (EUCTR) | 31/10/2018 | 11/07/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Farmacéutica, S.A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Portugal;Greece;Thailand;Spain;Costa Rica;Russian Federation;Colombia;Switzerland;Italy;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan | ||
| 39 | EUCTR2014-000162-22-RO (EUCTR) | 24/10/2018 | 27/07/2021 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules/ Cormeto Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | Hungary;Spain;Poland;Belgium;Turkey;Romania;Germany;Italy | ||
| 40 | NCT04045015 (ClinicalTrials.gov) | October 16, 2018 | 1/8/2019 | Liquorice and Salivary Cortisol | Effects of Liquorice on Salivary Cortisol and Cortisone | Cushing Syndrome;Hypercortisolism | Dietary Supplement: Liqourice | Umeå University | NULL | Recruiting | 18 Years | 65 Years | All | 30 | N/A | Sweden |
| 41 | NCT03697109 (ClinicalTrials.gov) | October 16, 2018 | 27/9/2018 | A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome | Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant | Cushing Syndrome | Drug: Relacorilant;Other: Placebo | Corcept Therapeutics | NULL | Recruiting | 18 Years | 80 Years | All | 130 | Phase 3 | United States;Austria;Bulgaria;Canada;Germany;Israel;Italy;Netherlands;Poland;Romania;Spain |
| 42 | NCT03606408 (ClinicalTrials.gov) | October 5, 2018 | 20/7/2018 | Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699 | An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety in Patients With Endogenous Cushing's Syndrome Who Have Completed a Prior Novartis-sponsored Osilodrostat (LCI699) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Osilodrostat | Cushing's Syndrome | Drug: osilodrostat | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 180 | Phase 2 | United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;China;Costa Rica;France;Germany;India;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Thailand;Turkey |
| 43 | EUCTR2017-002840-34-IT (EUCTR) | 01/10/2018 | 17/06/2021 | Roll-over study to assess long-term safety in patients with endogenous Cushing's syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat - NA | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Osilodrostat 1mg Product Code: [LCI699] INN or Proposed INN: Osilodrostat Product Name: Osilodrostat 5mg Product Code: [LCI699] INN or Proposed INN: Osilodrostat Product Name: Osilodrostat 10mg Product Code: [LCI699] INN or Proposed INN: Osilodrostat | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Portugal;Greece;Thailand;Costa Rica;Spain;Russian Federation;Colombia;Italy;Switzerland;India;France;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany | ||
| 44 | EUCTR2017-002840-34-AT (EUCTR) | 03/08/2018 | 22/05/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Recordati AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Portugal;Thailand;Spain;Costa Rica;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 45 | EUCTR2018-001616-30-IT (EUCTR) | 19/07/2018 | 29/01/2021 | Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome - - | Endogenous Cushing Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Trade Name: NA Product Name: NA Product Code: [CORT125134] INN or Proposed INN: Relacorilant | CORCEPT THERAPEUTICS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Hungary;Spain;Bulgaria;Germany;Italy | ||
| 46 | EUCTR2017-002840-34-DE (EUCTR) | 13/07/2018 | 29/05/2018 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Recordati AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Portugal;United States;Spain;Costa Rica;Thailand;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 47 | EUCTR2018-001616-30-HU (EUCTR) | 09/07/2018 | 14/05/2018 | Extension of a clinical trial to assess the safety of a study drug called CORT125134 in the treatment of Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome | Endogenous Cushing Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Relacorilant Other descriptive name: (R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE | Corcept Therapeutics Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Hungary;Italy | ||
| 48 | JPRN-jRCTs021180039 | 24/05/2018 | 26/03/2019 | The usefulness of DDAVP test and GHRP-2 test in patients with Cushing's disease | The usefulness of DDAVP test and GHRP-2 test in patients with Cushing's disease - Cushing_diagnosis | Cushing's disease | administration of DDAVP or GHRP-2 | Kageyama Kazunori | NULL | Recruiting | >= 15age old | Not applicable | Both | 15 | Phase 3 | Japan |
| 49 | EUCTR2017-001219-35-NL (EUCTR) | 24/05/2018 | 29/11/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 3 | France;United States;Hungary;Greece;Spain;Poland;Romania;Denmark;Bulgaria;Israel;Netherlands;Italy | ||
| 50 | EUCTR2017-001219-35-FR (EUCTR) | 23/05/2018 | 24/10/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 51 | EUCTR2017-001219-35-GR (EUCTR) | 08/05/2018 | 04/04/2018 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 52 | NCT03604198 (ClinicalTrials.gov) | May 7, 2018 | 1/5/2018 | Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome | Cushing Syndrome | Drug: relacorilant | Corcept Therapeutics | NULL | Enrolling by invitation | N/A | N/A | All | 75 | Phase 2 | United States;Austria;Bulgaria;Germany;Israel;Italy;Romania;Spain |
| 53 | EUCTR2017-001219-35-IT (EUCTR) | 20/02/2018 | 27/01/2021 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing¿s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing¿s Syndrome - - | Endogenous Cushing¿s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Levoketoconazole Product Code: [COR-003] INN or Proposed INN: levoketozonazole | CORTENDO AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 54 | EUCTR2017-001219-35-DK (EUCTR) | 14/02/2018 | 19/12/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 55 | EUCTR2017-001219-35-BG (EUCTR) | 23/01/2018 | 30/10/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 56 | EUCTR2017-001219-35-ES (EUCTR) | 22/01/2018 | 17/10/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Greece;Spain;Israel;Italy;France;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Netherlands | ||
| 57 | EUCTR2017-001219-35-PL (EUCTR) | 16/01/2018 | 28/11/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 24.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | Denmark;Bulgaria;Israel;Netherlands;Italy;France;United States;Hungary;Greece;Spain;Poland;Romania | ||
| 58 | EUCTR2017-001219-35-HU (EUCTR) | 12/01/2018 | 16/11/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing’s Syndrome | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open-label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S,4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing´s syndrome (CS) MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: levoketoconazole Product Code: COR-003 INN or Proposed INN: levoketozonazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | United States;France;Hungary;Greece;Spain;Poland;Romania;Denmark;Israel;Bulgaria;Netherlands;Italy | ||
| 59 | 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 | ||
| 60 | NCT03346954 (ClinicalTrials.gov) | December 11, 2017 | 15/11/2017 | Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease | Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease | Cushing's Disease | Other: [11C]-Methionine PET/MRI | Hospices Civils de Lyon | NULL | Completed | 18 Years | N/A | All | 33 | N/A | France |
| 61 | NCT03277690 (ClinicalTrials.gov) | September 26, 2017 | 7/9/2017 | A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome. | A Double-blind, Placebo-Controlled, Randomized Withdrawal Following Open Label Therapy Study to Assess the Safety and Efficacy of Levoketoconazole (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing's Syndrome | Endogenous Cushing's Syndrome | Drug: Levoketoconazole;Drug: Placebo | Cortendo AB | NULL | Completed | 18 Years | N/A | All | 44 | Phase 3 | United States;Bulgaria;Denmark;France;Greece;Hungary;Israel;Italy;Netherlands;Poland;Romania;Spain |
| 62 | 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 | |
| 63 | NCT03111810 (ClinicalTrials.gov) | May 25, 2017 | 17/3/2017 | Targeting Iatrogenic Cushing's Syndrome With 11ß-hydroxysteroid Dehydrogenase Type 1 Inhibition | Targeting Iatrogenic Cushing's Syndrome With 11ß-hydroxysteroid Dehydrogenase Type 1 Inhibition (TICSI) | Iatrogenic Cushing's Disease | Drug: AZD4017 and prednisolone;Drug: Placebo Oral Tablet and prednisolone | University of Oxford | AstraZeneca | Completed | 18 Years | 60 Years | Male | 32 | Phase 2 | United Kingdom |
| 64 | EUCTR2016-002240-17-GB (EUCTR) | 16/05/2017 | 06/03/2017 | A Study of ATR-101 for the Treatment of Cushing’s Syndrome | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing’s Syndrome | endogenous Cushing’s syndrome MedDRA version: 20.0;Level: SOC;Classification code 10014698;Term: Endocrine disorders;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ATR-101 INN or Proposed INN: Nevanimibe hydrochloride Other descriptive name: ATR-101; CI-984 | Millendo Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 16 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;United Kingdom | ||
| 65 | 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 | ||
| 66 | NCT03145285 (ClinicalTrials.gov) | April 18, 2017 | 26/4/2017 | Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma | Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma | Cushing Syndrome;Adrenocortical Carcinoma | Drug: Abiraterone Acetate | Azienda Ospedaliera Spedali Civili di Brescia | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano;Niguarda Hospital;San Camillo Hospital, Rome;San Luigi Gonzaga Hospital | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 2 | Italy |
| 67 | NCT03053271 (ClinicalTrials.gov) | April 13, 2017 | 6/2/2017 | A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing's Syndrome | Cushing Syndrome | Drug: ATR-101;Drug: Placebo | Millendo Therapeutics US, Inc. | NULL | Terminated | 18 Years | 80 Years | All | 4 | Phase 2 | United States;United Kingdom |
| 68 | EUCTR2016-003060-40-GB (EUCTR) | 17/01/2017 | 22/12/2016 | Treating side effects of steroid medication | Targeting Iatrogenic Cushing’s Syndrome with 11ß-hydroxysteroid dehydrogenase type 1 Inhibition - TICSI version 0.6 | Adverse effects of prescribed glucocorticoid therapy MedDRA version: 19.0;Level: LLT;Classification code 10068501;Term: Cushing's syndrome, steroid-induced;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: AZD4017 Product Code: AZD4017 INN or Proposed INN: no INN available Other descriptive name: AZD4017 | University of Oxford, Clinical Trials and Research Governance | NULL | Not Recruiting | Female: no Male: yes | 32 | Phase 2 | United Kingdom | ||
| 69 | EUCTR2016-000899-23-NL (EUCTR) | 20/12/2016 | 27/07/2016 | Clinical trial to assess the safety and effectiveness of a study drug called CORT125134 in the treatment of Cushing's syndrome | Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing’s Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Not Available | Corcept Therapeutics Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United States;Hungary;Netherlands;United Kingdom | ||
| 70 | EUCTR2015-004497-15-IT (EUCTR) | 12/12/2016 | 08/01/2018 | Endocrine cardiomyopathy in cushing syndrome: Response to cyclic GMP PDE5 inhibitOrs | Study on New Insights in Remodeling of Endocrine Cardiomyopathies: Intramyocardial, Molecular and Neuroendocrine Assessment in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A in Cushing’s Syndrome-Endocrine cardiomyopathy in cushing syndrome: Response to cyclic GMP PDE5 inhibitOrs - Endocrine cardiomyopathy in cushing syndrome: Response to cyclic GMP PDE5 inhibitOrs | Cushing’s Syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: CIALIS - 20 MG 2 COMPRESSE RIVESTITE CON FILM IN BLISTER USO ORALE Product Name: Tadalafil | UMBERTO I - POLICLINICO DI ROMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2 | Italy | ||
| 71 | EUCTR2016-000899-23-IT (EUCTR) | 08/11/2016 | 08/06/2021 | Clinical trial to assess the safety and effectiveness of a study drug called CORT125134 in the treatment of Cushing's syndrome | Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing¿s Syndrome - - | Endogenous Cushing¿s Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 MedDRA version: 20.0;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 | CORCEPT THERAPEUTICS | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Hungary;Netherlands;United Kingdom;Italy | ||
| 72 | EUCTR2014-004092-23-PT (EUCTR) | 14/10/2016 | 03/08/2016 | Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease | A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Belgium;Brazil;Poland;China | ||
| 73 | EUCTR2016-000899-23-HU (EUCTR) | 05/10/2016 | 30/06/2016 | Clinical trial to assess the safety and effectiveness of a study drug called CORT125134 in the treatment of Cushing's syndrome | Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing’s Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Not Available | Corcept Therapeutics Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United States;Hungary;Netherlands;United Kingdom | ||
| 74 | NCT02697734 (ClinicalTrials.gov) | October 3, 2016 | 27/2/2016 | Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease | A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's Disease | Cushing's Disease | Drug: osilodrostat;Drug: osilodrostat Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 73 | Phase 3 | United States;Belgium;Brazil;Canada;China;Costa Rica;Greece;Poland;Portugal;Russian Federation;Spain;Switzerland;Thailand;Turkey |
| 75 | EUCTR2014-004092-23-PL (EUCTR) | 08/09/2016 | 25/07/2016 | Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease | A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Poland;Belgium;Brazil;Denmark;China | ||
| 76 | EUCTR2016-000899-23-GB (EUCTR) | 16/08/2016 | 21/06/2016 | Clinical trial to assess the safety and effectiveness of a study drug called CORT125134 in the treatment of Cushing's syndrome | Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing’s Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Code: CORT125134 INN or Proposed INN: Relacorilant | Corcept Therapeutics Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Netherlands;United Kingdom | ||
| 77 | EUCTR2014-004092-23-BE (EUCTR) | 09/08/2016 | 18/05/2016 | Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease | A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Belgium;Brazil;Poland;China | ||
| 78 | EUCTR2014-000162-22-PL (EUCTR) | 27/07/2016 | 21/04/2016 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Hungary;Belgium;Spain;Poland;Romania;Turkey;Germany;Italy | ||
| 79 | EUCTR2014-004092-23-GR (EUCTR) | 05/07/2016 | 11/05/2016 | Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease | A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 | 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] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Poland;Brazil;Belgium;Turkey;Denmark;Russian Federation;Switzerland | ||
| 80 | NCT02611258 (ClinicalTrials.gov) | July 2016 | 16/11/2015 | Endocrine Cardiomyopathy in Cushing Syndrome: Response to Cyclic GMP PDE5 inhibitOrs | Study on New Insights in Remodeling of Endocrine Cardiomyopathies: Intramyocardial, Molecular and Neuroendocrine Assessment in Response to Chronic Inhibition of Cyclic GMP Phosphodiesterase 5A in Cushing's Syndrome | Cushing's Syndrome Cardiomyopathy | Drug: Tadalafil | Andrea M. Isidori | NULL | Unknown status | 18 Years | 75 Years | All | 18 | Phase 2 | Italy |
| 81 | EUCTR2016-000945-29-IT (EUCTR) | 16/06/2016 | 04/11/2020 | Activity of Abiraterone Acetate in the management of Cushing’s syndrome in patients with adrenocortical carcinoma (ABACUS) | Activity of Abiraterone Acetate in the management of Cushing’s syndrome in patients with adrenocortical carcinoma (ABACUS) - ABACUS | Cushing’s syndrome in patients with adrenocortical carcinoma MedDRA version: 20.0;Level: PT;Classification code 10001388;Term: Adrenocortical carcinoma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: ZYTIGA - 250 MG - COMPRESSA - USO ORALE - FLACONE 120 COMPRESSE Product Name: ZYTIGA Product Code: [ZYTIGA] INN or Proposed INN: abiraterone acetato | AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Italy | ||
| 82 | NCT02804750 (ClinicalTrials.gov) | June 2016 | 15/6/2016 | Study to Evaluate CORT125134 in Participants With Cushing's Syndrome | Phase 2 Study of the Safety and Efficacy of CORT125134 in the Treatment of Endogenous Cushing's Syndrome | Cushing's Syndrome | Drug: CORT125134 | Corcept Therapeutics | NULL | Completed | 18 Years | 80 Years | All | 35 | Phase 2 | United States;Hungary;Italy;Netherlands;United Kingdom |
| 83 | EUCTR2014-004092-23-ES (EUCTR) | 29/04/2016 | 18/03/2016 | Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease | A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing?s disease - LINC-4 | 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] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 69 | Phase 3 | United States;Greece;Poland;Brazil;Belgium;Thailand;Spain;Turkey;Denmark;Russian Federation;Switzerland | ||
| 84 | EUCTR2013-002133-37-HU (EUCTR) | 05/04/2016 | 24/09/2015 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;Sweden | ||
| 85 | EUCTR2013-002133-37-CZ (EUCTR) | 22/02/2016 | 27/07/2015 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 86 | 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 | ||
| 87 | EUCTR2013-002133-37-BG (EUCTR) | 15/10/2015 | 07/07/2015 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 88 | EUCTR2014-000162-22-HU (EUCTR) | 06/10/2015 | 08/07/2015 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 18.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | Hungary;Spain;Poland;Belgium;Germany;Italy | ||
| 89 | JPRN-UMIN000018891 | 2015/10/01 | 01/10/2015 | The usefulness of DDAVP test and GHRP-2 test in patients with Cushing's disease | Cushing's disease | administration of DDAVP or GHRP-2 | Department of Endocrinology and Metabolism, Hirosaki University Graduate School of Medicine | NULL | Recruiting | 15years-old | Not applicable | Male and Female | 15 | Not selected | Japan | |
| 90 | 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 |
| 91 | EUCTR2013-002133-37-DE (EUCTR) | 23/09/2015 | 12/06/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;Belgium;Romania;Denmark;Georgia;Bulgaria;Netherlands;Germany;Sweden | ||
| 92 | EUCTR2013-002133-37-DK (EUCTR) | 31/07/2015 | 20/03/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Sweden | ||
| 93 | 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 | ||
| 94 | NCT02484755 (ClinicalTrials.gov) | June 2015 | 21/6/2015 | Targeted Therapy With Gefitinib in Patients With USP8-mutated Cushing's Disease | Targeted Therapy With Gefitinib in Patients With USP8-mutated Cushing's Disease | Cushing's Disease;Corticotrophin Adenoma | Drug: Gefitinib | Huashan Hospital | NULL | Recruiting | 18 Years | 70 Years | Both | 6 | Phase 2 | China |
| 95 | 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 | ||
| 96 | EUCTR2014-000162-22-DE (EUCTR) | 04/05/2015 | 30/10/2014 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | Hungary;Spain;Poland;Belgium;Turkey;Romania;Germany;Italy | ||
| 97 | NCT02297945 (ClinicalTrials.gov) | April 2015 | 19/11/2014 | Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome | Prospective, Single Arm, Open-label, Multicenter, International Study to Assess the Effects of Metyrapone in Patients With Endogenous Cushing's Syndrome During a 12-week Treatment Period Followed by an Extension Period of 24 Weeks | Cushing's Syndrome | Drug: metyrapone | HRA Pharma | NULL | Completed | 18 Years | N/A | All | 50 | Phase 3 | Belgium;Germany;Hungary;Italy;Poland;Romania;Spain;Turkey |
| 98 | 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 | ||
| 99 | EUCTR2014-000162-22-IT (EUCTR) | 19/03/2015 | 25/11/2014 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 17.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules/Cormeto Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | United States;Hungary;Spain;Poland;Belgium;Germany;Switzerland;Italy;Sweden | ||
| 100 | 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 | |||
| 101 | EUCTR2014-000162-22-BE (EUCTR) | 11/03/2015 | 04/12/2014 | Study to assess the effects of metyrapone in patients with Cushing’s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing’s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing’s syndrome MedDRA version: 17.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules Product Name: metyrapone | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | United States;Hungary;Spain;Poland;Belgium;Germany;Switzerland;Italy;Sweden | ||
| 102 | EUCTR2014-000162-22-ES (EUCTR) | 23/02/2015 | 16/01/2015 | Study to assess the effects of metyrapone in patients with Cushing?s syndrome during a 12-week treatment period | Prospective, single arm, open-label, multicenter, international study to assess the effects of metyrapone in patients with endogenous Cushing?s syndrome during a 12-week treatment period followed by an extension period of 24 weeks. - PROMPT | Treatment of Cushing?s syndrome MedDRA version: 17.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Metopirone 250 mg capsules Product Name: metyrapone INN or Proposed INN: METYRAPONE | Laboratoire HRA Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Hungary;Poland;Belgium;Spain;Germany;Italy;Switzerland;Sweden | ||
| 103 | EUCTR2013-004766-34-NL (EUCTR) | 04/02/2015 | 21/08/2014 | Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Thailand;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 104 | NCT02574793 (ClinicalTrials.gov) | December 1, 2014 | 9/10/2015 | Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects | Characteristics of Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects | Pituitary Adenoma | Device: continuous glucose monitoring | Huashan Hospital | NULL | Completed | N/A | N/A | All | 60 | China | |
| 105 | EUCTR2013-004766-34-FR (EUCTR) | 28/11/2014 | 08/02/2019 | Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 20mg Product Code: LCI699 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 106 | EUCTR2013-004766-34-GB (EUCTR) | 20/11/2014 | 22/07/2014 | Safety and efficacy of LCI699 for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 107 | EUCTR2013-002133-37-GB (EUCTR) | 17/11/2014 | 18/06/2013 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 108 | EUCTR2013-002133-37-IT (EUCTR) | 17/11/2014 | 04/09/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) MedDRA version: 17.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Bulgaria;Georgia;Germany;Netherlands;Sweden | ||
| 109 | NCT02180217 (ClinicalTrials.gov) | October 6, 2014 | 17/6/2014 | Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease | Phase III, Multi-center, Double-blind, Randomized Withdrawal Study of LCI699 Following a 24 Week, Single-arm, Open-label Dose Titration and Treatment Period to Evaluate the Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease | Cushings Disease | Drug: osilodrostat;Drug: LCI699 matching placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 137 | Phase 3 | United States;Argentina;Austria;Bulgaria;Canada;China;Colombia;France;Germany;India;Italy;Japan;Korea, Republic of;Netherlands;Russian Federation;Spain;Thailand;Turkey;United Kingdom;Australia |
| 110 | EUCTR2013-004766-34-DE (EUCTR) | 06/10/2014 | 29/07/2014 | Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: osilodrostat 1mg Product Code: LCI699, 1 mg INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 5mg Product Code: LCI699, 5 mg INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 10mg Product Code: LCI699, 10 mg INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 20mg Product Code: LCI699, 20 mg INN or Proposed INN: osilodrostat Other descriptive name: LCI699 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Thailand;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 111 | EUCTR2013-002133-37-SE (EUCTR) | 18/09/2014 | 12/03/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 19.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 112 | 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 | ||
| 113 | EUCTR2013-004766-34-ES (EUCTR) | 13/08/2014 | 11/08/2014 | Safety and efficacy of LCI699 for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing?s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Code: LCI699 INN or Proposed INN: LCI699 Other descriptive name: LCI699 Product Code: LCI699 INN or Proposed INN: LCI699 Other descriptive name: LCI699 Product Code: LCI699 INN or Proposed INN: LCI699 Other descriptive name: LCI699 Product Code: LCI699 INN or Proposed INN: LCI699 Other descriptive name: LCI699 | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 114 | EUCTR2013-004766-34-AT (EUCTR) | 05/08/2014 | 31/07/2014 | Safety and efficacy of osilodrostat (LCI699) for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Other descriptive name: LCI699 Product Name: osilodrostat 20mg Product Code: LCI699 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Thailand;Turkey;Austria;Russian Federation;Colombia;Italy;United Kingdom;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 115 | EUCTR2013-004766-34-IT (EUCTR) | 01/08/2014 | 13/06/2014 | Safety and efficacy of LCI699 for the treatment of patients with Cushing's disease | A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing’s disease | Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: NA Product Code: LCI699 INN or Proposed INN: NA Other descriptive name: LCI699 Product Name: NA Product Code: LCI699 INN or Proposed INN: NA Other descriptive name: LCI699 Product Name: NA Product Code: LCI699 INN or Proposed INN: NA Other descriptive name: LCI699 Product Name: NA Product Code: LCI699 INN or Proposed INN: NA Other descriptive name: LCI699 | NOVARTIS FARMA S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Korea, Republic of;Japan;China;Germany;Netherlands;Bulgaria;Australia;Argentina;Canada;France;India;Italy;United Kingdom;Colombia;Russian Federation;Austria;Turkey;Spain;Thailand;Slovakia;Taiwan | ||
| 116 | NCT01838551 (ClinicalTrials.gov) | August 2014 | 19/4/2013 | Treatment for Endogenous Cushing's Syndrome | An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome | Endogenous Cushing's Syndrome | Drug: Levoketoconazole | Cortendo AB | NULL | Completed | 18 Years | N/A | All | 90 | Phase 3 | United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Serbia;Spain;Turkey;Czech Republic;Georgia;Hungary;Sweden;Switzerland;United Kingdom |
| 117 | EUCTR2013-002133-37-NL (EUCTR) | 10/07/2014 | 11/03/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Germany;Netherlands;Sweden | ||
| 118 | EUCTR2013-002133-37-BE (EUCTR) | 09/07/2014 | 11/02/2014 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have Cushing’s Syndrome or Cushing's Disease | An Open Label Study to Assess the Safety and Efficacy of COR—003 (2S, 4R-Ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome | Endogenous Cushing's syndrome (CS) or Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 Product Code: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole, levoketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Serbia;United States;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;Sweden | ||
| 119 | JPRN-UMIN000041513 | 2014/07/01 | 01/09/2020 | A new perioperative glucocorticosteroid replacement therapy for cushing syndrome | A new perioperative glucocorticosteroid replacement therapy for cushing syndrome - A perioperative glucocorticosteroid replacement therapy | Perioperative | Hydrocortisone was given during adrenal resection by intravenous injectionon the surgical day. | Tianjin Medical University General Hospital | NULL | Recruiting | 22years-old | 61years-old | Male and Female | 80 | Not selected | Asia(except Japan) |
| 120 | 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 | ||
| 121 | EUCTR2013-002133-37-ES (EUCTR) | 26/05/2014 | 12/11/2013 | A clinical study to find out whether a new drug known as COR-003 is safe and effective in people who have a medical condition in which they produce too much of a steriod hormone known as cortisol | An Open Label Study to Assess the Safety and Efficiacy of COR-003 (2S,4R- Ketoconazole) in the Treatment of Endogenous Cushing's Syndrome (CS) Estudio abierto para evaluar la seguridad y la eficacia del producto COR-003 (2S, 4R-ketoconazol) en el tratamiento del síndrome de Cushing endógeno (SC) | Endogenous Cushing's syndrome (CS) MedDRA version: 16.1;Level: LLT;Classification code 10011657;Term: Cushings syndrome;System Organ Class: 100000004860 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: COR-003 INN or Proposed INN: Not available Other descriptive name: 2S,4R-(-)-ketoconazole | Cortendo AB | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Austria;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Denmark;Bulgaria;Netherlands;Germany;China;Sweden | ||
| 122 | 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 |
| 123 | NCT02160730 (ClinicalTrials.gov) | May 2014 | 21/5/2014 | Treatment of Cushing's Disease With R-roscovitine | Treatment of Pituitary Cushing Disease With a Selective CDK Inhibitor, R-roscovitine | Cushings Disease | Drug: R-roscovitine | Shlomo Melmed, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Terminated | 18 Years | N/A | All | 4 | Phase 2 | United States |
| 124 | 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 | ||
| 125 | NCT01915303 (ClinicalTrials.gov) | March 6, 2014 | 10/6/2013 | 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 of Pasireotide s.c. Alone or in Combination With Cabergoline in Patients With Cushing's Disease | Cushings Disease | Drug: Pasireotide with or without cabergoline | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 68 | Phase 2 | United States;Argentina;Belgium;Brazil;Colombia;France;Germany;Greece;Hungary;India;Italy;Malaysia;Mexico;Netherlands;Spain;Turkey;Australia;Bulgaria;Venezuela |
| 126 | NCT02019706 (ClinicalTrials.gov) | February 12, 2014 | 21/12/2013 | Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing Syndrome | Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing Syndrome | ACTH;Cushing's Syndrome | Radiation: DOTATATE PET-CT;Radiation: F-DOPA PET CT;Radiation: CT scan;Diagnostic Test: Routine MRI scan;Diagnostic Test: Gated MRI scan;Drug: 68Ga-DOTATATE;Drug: 18F-DOPA | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | 18 Years | 80 Years | All | 80 | Phase 2 | United States |
| 127 | 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 | ||
| 128 | EUCTR2013-002170-49-GR (EUCTR) | 29/01/2014 | 24/01/2014 | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients 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 | Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE 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 | 128 | Phase 2 | United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany | ||
| 129 | 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 | ||
| 130 | EUCTR2013-002170-49-FR (EUCTR) | 27/12/2013 | 03/12/2015 | A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients 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 | Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: PASIREOTIDE DIASPARTATE Trade Name: CABERGOLINE TEVA Product Name: Cabergoline Other descriptive name: CABERGOLINE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | 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 | ||
| 131 | 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 | ||
| 132 | 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 | ||
| 133 | 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 | ||
| 134 | 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 | |||
| 135 | NCT01925092 (ClinicalTrials.gov) | August 2013 | 8/8/2013 | Mifepristone in Children With Refractory Cushing's Disease | An Open-label Study of the Safety, Pharmacokinetics and Pharmacodynamics of Mifepristone in Children With Refractory Cushing's Disease | Cushing's Disease | Drug: mifepristone | Corcept Therapeutics | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Withdrawn | 6 Years | 17 Years | Both | 0 | Phase 3 | United States |
| 136 | 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 | United States;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;China |
| 137 | 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 | |||
| 138 | 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 | ||
| 139 | NCT03080181 (ClinicalTrials.gov) | May 2013 | 3/3/2017 | Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment | Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters | Cushing Disease | Drug: Pasireotide 0.6 MG/ML | University of Palermo | NULL | Completed | 18 Years | N/A | All | 24 | Phase 4 | NULL |
| 140 | NCT02310269 (ClinicalTrials.gov) | March 28, 2013 | 26/9/2014 | Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease | Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study) | Cushings Disease | Drug: SOM230 | RECORDATI GROUP | NULL | Recruiting | 18 Years | N/A | All | 200 | United States;Canada;Colombia;France;Germany;Israel;Italy;Lebanon;Netherlands;Romania;Sweden;United Kingdom;Denmark | |
| 141 | NCT01319994 (ClinicalTrials.gov) | July 2012 | 21/2/2011 | Prevention of Metabolic Complications of Glucocorticoid Excess | Prevention of Metabolic Complications of Glucocorticoid Excess - a Randomised, Doubleblind,Placebo Controlled Study | Iatrogenic Cushing Disease | Drug: Metformin;Drug: Placebo | Barts & The London NHS Trust | Barts and the London School of Medicine and Dentistry | Completed | 18 Years | 75 Years | All | 57 | Phase 2/Phase 3 | United Kingdom |
| 142 | EUCTR2010-024165-44-NL (EUCTR) | 24/04/2012 | 22/12/2011 | Study 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: 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 Code: SOM230 INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Germany;Czech Republic;Egypt;Netherlands;Argentina;Korea, Republic of;Romania;Thailand;Spain;Greece;Brazil | |||
| 143 | NCT02889224 (ClinicalTrials.gov) | February 2012 | 30/8/2016 | In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man | In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man | Cushing's Syndrome | Other: Obese;Procedure: Hypercortisolism;Other: Hydrocortisone;Other: Control | University Hospital, Bordeaux | NULL | Completed | 18 Years | N/A | All | 40 | N/A | France |
| 144 | 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 | ||
| 145 | 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 |
| 146 | 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 | ||||
| 147 | 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 | ||
| 148 | 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 | ||
| 149 | 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 |
| 150 | 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 | ||
| 151 | 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 | ||
| 152 | EUCTR2009-011128-70-ES (EUCTR) | 22/09/2011 | 18/07/2011 | Estudio de fase III, de muchos centros, aleatorizado a dos dosis distintas de medicación sin que el médico ni el paciente sepa en cual está, para evaluar la eficacia y seguridad de pasireotida LAR (de larga duración) en pacientes con enfermedad de Cushing. | Estudio de fase III, multicéntrico, aleatorizado y doble ciego, para evaluar la eficacia y seguridad de pasireotida LAR en pacientes con enfermedad de Cushing | Enfermedad de Cushing 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: pasireotide Product Code: SOM230 INN or Proposed INN: Pasireotide Product Name: pasireotide Product Code: SOM230 INN or Proposed INN: Pasireotide | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | United States;Spain;Thailand;Turkey;Japan;China;Germany;Peru;Singapore;Brazil;Belgium;Poland;Argentina;Canada;United Kingdom;Italy;Russian Federation | ||
| 153 | 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 | |||
| 154 | 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 | ||
| 155 | 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 | ||
| 156 | NCT01582061 (ClinicalTrials.gov) | August 16, 2011 | 12/4/2012 | An Open-label, Multi-center, Expanded Access Study 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). | Cushing's Disease | Drug: Pasireotide sub-cutaneous | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 104 | Phase 3 | United States;Brazil;Czechia;Germany;Greece;Korea, Republic of;Lebanon;Romania;Russian Federation;Spain;Thailand;Czech Republic;Egypt;Netherlands |
| 157 | EUCTR2010-024165-44-GR (EUCTR) | 09/08/2011 | 22/06/2011 | An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - 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: 14.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders | Product Name: N/A Product Code: SOM230 INN or Proposed INN: pasireotide Other descriptive name: - INN or Proposed INN: pasireotide INN or Proposed INN: pasireotide | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Czech Republic;Greece;Spain;Netherlands;Germany | |||
| 158 | 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 | ||
| 159 | EUCTR2010-022403-22-IT (EUCTR) | 04/07/2011 | 20/09/2011 | Open-label, multicenter study to assess the safety/tolerability and efficacy of 10-weeks treatment of LCI699 in patients with Cushing’s disease | A proof-of concept, open-label, forced titration, multicenter study to assess the safety/tolerability and efficacy of 10-weeks treatment of LCI699 in patients with Cushing’s disease | Cushing's disease MedDRA version: 14.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: LCI699 Product Code: LCI699 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | United States;Italy | ||
| 160 | NCT01331239 (ClinicalTrials.gov) | March 23, 2011 | 6/4/2011 | Safety and Efficacy of LCI699 in Cushing's Disease Patients. | A Proof of Concept, Open-label, Forced Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of 10-weeks Treatment of LCI699 Followed by a 12 - Week Treatment Period of LCI699 in Patients With Cushing's Disease | Cushing's Disease | Drug: LCI699 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 33 | Phase 2 | United States;France;Italy;Japan |
| 161 | NCT01371565 (ClinicalTrials.gov) | November 2010 | 7/6/2011 | Compassionate Use of CORLUX® (Mifepristone) in the Treatment of Signs and Symptoms of Endogenous Cushing's Syndrome | Compassionate Use Protocol for the Administration of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome | Cushing's Disease;Cushing's Syndrome | Drug: Mifepristone | Corcept Therapeutics | NULL | Completed | 18 Years | N/A | All | 4 | Phase 3 | United States |
| 162 | EUCTR2008-005708-18-GB (EUCTR) | 04/06/2010 | 14/04/2010 | Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess | Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess | Rheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndrome | Trade Name: Glucophage (metformin) Product Name: Metformin | Queen Mary University of London | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 163 | 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 | |||
| 164 | JPRN-UMIN000002925 | 2009/12/01 | 28/12/2009 | Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension. | Efficacy of Eplerenone monotherapy and Valsartan monotherapy on patients of Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension. - A pilot study to compare efficacy of Eplerenone monotherapy with Valsartan monotherapy. | Subclinical Cushing's syndrome with hypertension and non-functioning adrenocortical adenoma with hypertension. | 50mg of Eplerenone monotherapy once daily for 6 weeks on subclinical Cushing's syndrome 80mg of Valsartan monotherapy once daily for 6 weeks on subclinical Cushing's syndrome 50mg of Eplerenone monotherapy once daily for 6 weeks on non-functioning adrenocortical adenoma 80mg of Valsartan monotherapy once daily for 6 weeks on non-functioning adrenocortical adenoma | Hiroshima University HospitalDepartment of Endocrinology and Diabetes mellitus | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 80 | Not selected | Japan |
| 165 | EUCTR2009-010918-30-IE (EUCTR) | 11/08/2009 | 11/03/2009 | Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. | Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism. | 20 patients with hypopituitarism including growth hormone deficiency will be evaluated both on growth hormone replacement and when they have been off it for a 2 month period. They will have been prescribed growth hormone replacement in the form of Genotropin/Genotropin Miniquick/Norditropin prior to inclusion in this study as part of their routine clinical care. MedDRA version: 9.1;Level: LLT;Classification code 10021067;Term: Hypopituitarism MedDRA version: 9.1;Classification code 10033662;Term: Panhypopituitarism MedDRA version: 9.1;Classification code 10056438;Term: Growth hormone deficiency MedDRA version: 9.1;Classification code 10011318;Term: Craniopharyngioma MedDRA version: 9.1;Classification code 10036832;Term: Prolactinoma MedDRA version: 9.1;Classification code 10011651;Term: Cushing's disease MedDRA version: 9.1;Classification code 10035104;Term: Pituitary tumour MedDRA version: 9.1;Classification code 10061538;Term: Pituitary tumour benign | Trade Name: Genotropin 5.3mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin 12mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.2mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.4mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.6mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 0.8mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 1.0mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniquick 1.2mg INN or Proposed INN: SOMATROPIN Trade Name: Genotropin Miniqu | Amar Agha, Beaumont Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Ireland | |||
| 166 | NCT00936741 (ClinicalTrials.gov) | July 2009 | 9/7/2009 | An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome | An Open Label Extension Study of the Efficacy and Safety of CORLUX® (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome | Cushing's Syndrome | Drug: mifepristone | Corcept Therapeutics | NULL | Completed | 18 Years | N/A | All | 30 | Phase 3 | United States |
| 167 | EUCTR2007-007604-15-GB (EUCTR) | 03/03/2009 | 21/08/2008 | A Pilot Study of the Effect of Glucocorticoid Receptor Antagonism in Patients with Sub-Clinical Cushing's Syndrome - Glucocorticoid Receptor Antagonism in Sub-Clinical Cushings | A Pilot Study of the Effect of Glucocorticoid Receptor Antagonism in Patients with Sub-Clinical Cushing's Syndrome - Glucocorticoid Receptor Antagonism in Sub-Clinical Cushings | Sub Clinical Cushing's Syndrome MedDRA version: 9.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome | Trade Name: mifedren Product Name: HRA052015 (mifepristone) Product Code: HRA052015 INN or Proposed INN: MIFEPRISTONE | Sheffield Teaching Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 6 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 168 | NCT00796783 (ClinicalTrials.gov) | February 2009 | 20/11/2008 | A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia | A Study to Confirm the Presence of Recurrent or Persistent Cushing's Syndrome in Patients With Clinical Signs or Symptoms of Hypercortisolemia Who Have Been Treated for Cushing's Disease | Cushing's Syndrome | Drug: Cushing's syndrome confirmation | Corcept Therapeutics | NULL | Terminated | 18 Years | N/A | Both | 2 | N/A | United States |
| 169 | NCT00845351 (ClinicalTrials.gov) | November 2008 | 16/2/2009 | Preoperative Bexarotene Treatment for Cushing's Disease | Preoperative Bexarotene Treatment for Cushing's Disease | Cushing's Disease | Drug: Bexarotene | University of Virginia | NULL | Recruiting | 18 Years | 65 Years | Both | 6 | Phase 1/Phase 2 | United States |
| 170 | NCT00721201 (ClinicalTrials.gov) | November 2008 | 21/7/2008 | Glucocorticoid Receptor Antagonism in Subclinical Cushings | A Pilot Study of the Effect of a Glucocorticoid Receptor Antagonist in Patients With Subclinical Cushings | Subclinical Cushing's | Drug: Mifepristone | Sheffield Teaching Hospitals NHS Foundation Trust | HRA Pharma | Completed | 18 Years | N/A | All | 6 | Phase 1/Phase 2 | United Kingdom |
| 171 | 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 | |||
| 172 | EUCTR2008-006379-65-IT (EUCTR) | 27/10/2008 | 12/11/2008 | Evaluation of the benefit-risk profile of retinoic acid in the treatment of Cushing`s disease - Retinoic acid in Cushing`s disease | Evaluation of the benefit-risk profile of retinoic acid in the treatment of Cushing`s disease - Retinoic acid in Cushing`s disease | sperimentation only in patients | INN or Proposed INN: Tretinoin | ISTITUTO AUXOLOGICO ITALIANO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 173 | EUCTR2008-002280-14-FR (EUCTR) | 18/07/2008 | 06/06/2008 | Comparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trial | Comparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trial | The Active substance of Osteopor is Ossein Hydroxyapatite.Treatment of processes characterized by decalcification: osteoporosis, Cushing syndrome, thyrotoxicosis. MedDRA version: 9.1;Level: LLT;Classification code 10006956;Term: Calcium deficiency | Trade Name: OSTEOPOR Product Name: OSTEOPOR Product Code: L0006CP03A INN or Proposed INN: ossein hydroxyapatite Trade Name: OROCAL Product Name: OROCAL INN or Proposed INN: calcium carbonate | Pierre Fabre Médicament | NULL | Not Recruiting | Female: yes Male: no | 60 | Phase 3 | France | ||
| 174 | 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 | ||
| 175 | 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 | |||
| 176 | NCT00569582 (ClinicalTrials.gov) | December 2007 | 5/12/2007 | A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome | An Open-label Study of the Efficacy and Safety of CORLUX (Mifepristone) in the Treatment of the Signs and Symptoms of Endogenous Cushing's Syndrome | Cushing's Syndrome | Drug: mifepristone | Corcept Therapeutics | NULL | Completed | 18 Years | N/A | All | 50 | Phase 3 | United States |
| 177 | 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 | |||
| 178 | NCT00889525 (ClinicalTrials.gov) | November 2007 | 27/4/2009 | Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor | Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor | Cushing's Disease;Corticotroph Adenoma | Drug: Cabergoline | Seth Gordhandas Sunderdas Medical College | NULL | Completed | 12 Years | N/A | Both | Phase 3 | India | |
| 179 | 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 |
| 180 | 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 | |||
| 181 | 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 | ||||
| 182 | 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 | |||
| 183 | 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 | |||
| 184 | 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 |
| 185 | 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 | |||
| 186 | 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 | |||
| 187 | 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 | ||
| 188 | 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 | |||
| 189 | 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 | |||
| 190 | 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 | |||
| 191 | 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 | |||
| 192 | NCT00434148 (ClinicalTrials.gov) | December 2006 | 9/2/2007 | Safety and Efficacy of Different Dose Levels of Pasireotide 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) Subcutaneous (sc) Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's Disease | Cushing's Disease | Drug: Pasireotide | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 162 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;China;Denmark;Finland;France;Germany;Greece;Israel;Italy;Mexico;Poland;Portugal;Spain;Turkey |
| 193 | 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 | |||
| 194 | EUCTR2006-005218-11-IT (EUCTR) | 15/09/2006 | 03/04/2007 | EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROME | EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROME | Cushing syndrome MedDRA version: 9.1;Level: LLT;Classification code 10011652;Term: Cushing's syndrome | Trade Name: DOSTINEX Trade Name: NIZORAL | ASSOCIAZIONE ITALIANA ENDOCRINOLOGIA-METABOLISMO-IPOFISI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 195 | NCT01959711 (ClinicalTrials.gov) | January 2006 | 6/10/2013 | Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Laparoscopic Adrenalectomy | Randomized Clinical Trial of Posterior Retroperitoneoscopic Adrenalectomy Versus Lateral Transperitoneal Laparoscopic Adrenalectomy With a Five-year Follow-up | Adrenal Tumor;Pheochromocytoma;Conn's Syndrome;Cushing's Syndrome | Procedure: Posterior RA;Procedure: Lateral transperitoneal LA | Jagiellonian University | NULL | Completed | 18 Years | 80 Years | Both | 65 | Phase 4 | Poland |
| 196 | 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 | |||
| 197 | 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 | |||
| 198 | NCT00171951 (ClinicalTrials.gov) | August 2004 | 13/9/2005 | Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's Disease | Extension Study to Assess the Safety and Efficacy of Pasireotide in Patients With Cushing's Disease | Cushing Disease | Drug: Pasireotide | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 19 | Phase 2 | United States;France;Germany;Italy;United Kingdom |
| 199 | NCT00088608 (ClinicalTrials.gov) | April 2004 | 30/7/2004 | A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease | A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in Patients With Cushing's Disease | Cushing's Syndrome | Drug: SOM230 s.c. | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 80 Years | Both | 26 | Phase 2 | United States;France;Italy;United Kingdom |
| 200 | NCT00001849 (ClinicalTrials.gov) | February 26, 1999 | 3/11/1999 | New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome | New Imaging Modalities in the Evaluation of Patients With Ectopic Cushing's Syndrome | Cushing Syndrome;Endocrine Disease | Drug: Pentetreotide;Drug: 18F-DOPA | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NULL | Completed | 18 Years | 90 Years | All | 98 | Phase 1/Phase 2 | United States |
| 201 | NCT03575247 (ClinicalTrials.gov) | January 1, 1998 | 20/6/2018 | The Risk of Adrenal Insufficiency and Cushing Syndrome Associated With Glucocorticoid Therapy in People With Chronic Inflammatory Diseases | The Risk of Adrenal Insufficiency and Cushing Syndrome Associated With Glucocorticoid Therapy in People With Chronic Inflammatory Diseases | Adrenal; Insufficiency Gluccorticoid-Induced;Cushing; Syndrome or Disease, Glucocorticoid-Induced | Drug: Glucocorticoids | University of Leeds | NULL | Completed | 18 Years | N/A | All | 111804 | NULL | |
| 202 | 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 |
| 203 | EUCTR2017-002840-34-PL (EUCTR) | 05/03/2020 | Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study | An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | Cushing's syndrome MedDRA version: 20.0;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Recordati AG | NULL | NA | Female: yes Male: yes | 200 | Phase 2 | United States;Portugal;Thailand;Spain;Costa Rica;Turkey;Austria;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Netherlands;Germany;Japan;China;Korea, Republic of |