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 | 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 | ||
| 2 | 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 |
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 |
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 |
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 |
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 | ||
| 39 | 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 | ||
| 40 | 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 | ||
| 41 | 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 |
| 42 | 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 | |
| 43 | 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 | ||
| 44 | 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 | ||
| 45 | 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 | ||
| 46 | 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 | ||
| 47 | 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 | ||
| 48 | 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 | ||
| 49 | 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 | ||
| 50 | 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 |
| 51 | 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 | ||
| 52 | 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 | ||
| 53 | 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 | ||
| 54 | 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 | ||
| 55 | 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 | ||
| 56 | 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 |
| 57 | 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 | ||
| 58 | 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 | ||
| 59 | 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 | |||
| 60 | 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 | ||
| 61 | 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 | ||
| 62 | 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 | ||
| 63 | 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 | ||
| 64 | 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 | ||
| 65 | 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 | ||
| 66 | 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 |
| 67 | 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 | ||
| 68 | 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 | ||
| 69 | 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 | ||
| 70 | 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 | ||
| 71 | 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 | ||
| 72 | 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 | ||
| 73 | 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 |
| 74 | 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 | ||
| 75 | 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 | ||
| 76 | 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 | ||
| 77 | 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 | ||
| 78 | 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 |
| 79 | 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 | ||
| 80 | 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 | |||
| 81 | 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 |
| 82 | 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 |
| 83 | 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 | |||
| 84 | 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 | ||
| 85 | 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 | |||
| 86 | 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 | ||
| 87 | 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 |
| 88 | 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 | ||
| 89 | 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 | ||
| 90 | 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 | ||
| 91 | 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 | ||
| 92 | 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 | ||
| 93 | 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 | |||
| 94 | 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 | ||
| 95 | 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 |
| 96 | 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 | |||
| 97 | 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 | ||
| 98 | 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 | ||
| 99 | 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 |
| 100 | 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 |
| 101 | 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 | ||
| 102 | 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 |
| 103 | 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 |
| 104 | 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 | ||||
| 105 | 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 | |||
| 106 | 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 |
| 107 | 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 | |||
| 108 | 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 | |||
| 109 | 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 | |||
| 110 | 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 |
| 111 | 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 | |||
| 112 | 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 | |||
| 113 | 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 |
| 114 | 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 |