75. クッシング病 Cushing disease Clinical trials / Disease details
臨床試験数 : 205 / 薬物数 : 176 - (DrugBank : 45) / 標的遺伝子数 : 61 - 標的パスウェイ数 : 127
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03708900 (ClinicalTrials.gov) | April 28, 2021 | 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 | RECORDATI GROUP | NULL | Recruiting | 6 Years | 17 Years | All | 12 | Phase 2 | Belgium;Bulgaria;Italy;Slovenia;United Kingdom |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | United States;Slovenia;Spain;Belgium;Bulgaria;United Kingdom;Italy | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | RECORDATI GROUP | NULL | Active, not 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 |
| 14 | 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 | ||
| 15 | 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 | Not Recruiting | 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 | ||
| 16 | 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 | ||
| 17 | EUCTR2014-004092-23-PT (EUCTR) | 14/10/2016 | 03/08/2016 | Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease | A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Belgium;Brazil;Poland;China | ||
| 18 | EUCTR2014-004092-23-PL (EUCTR) | 08/09/2016 | 25/07/2016 | Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease | A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Poland;Belgium;Brazil;Denmark;China | ||
| 19 | EUCTR2014-004092-23-BE (EUCTR) | 09/08/2016 | 18/05/2016 | Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease | A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 | Cushing's disease MedDRA version: 20.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | United States;Portugal;Greece;Costa Rica;Spain;Thailand;Turkey;Russian Federation;Switzerland;Canada;Belgium;Brazil;Poland;China | ||
| 20 | EUCTR2014-004092-23-GR (EUCTR) | 05/07/2016 | 11/05/2016 | Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease | A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease - LINC-4 | Cushing's disease MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Poland;Brazil;Belgium;Turkey;Denmark;Russian Federation;Switzerland | ||
| 21 | EUCTR2014-004092-23-ES (EUCTR) | 29/04/2016 | 18/03/2016 | Placebo-controlled study of the safety and efficacy of osilodrostat in patients with Cushing's Disease | A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing?s disease - LINC-4 | Cushing's disease MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: osilodrostat 1mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 5mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 10mg Product Code: LCI699 INN or Proposed INN: osilodrostat Product Name: osilodrostat 20mg Product Code: LCI699 INN or Proposed INN: osilodrostat | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | Portugal;United States;Greece;Thailand;Poland;Brazil;Belgium;Spain;Turkey;Denmark;Russian Federation;Switzerland | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | Colombia;Argentina;Russian Federation;United States;Japan;United Kingdom;Thailand;India;Spain;Canada;Austria;Netherlands;Turkey;China;Korea, Republic of;Italy;Australia;Bulgaria;France;Germany | ||
| 25 | 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 | ||
| 26 | 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 |
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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;Taiwan;Slovakia;Thailand;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Italy;India;France;Canada;Argentina;Australia;Bulgaria;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 30 | 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 | ||
| 31 | 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 |
| 32 | 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 |