89. リンパ脈管筋腫症 Lymphangioleiomyomatosis Clinical trials / Disease details
臨床試験数 : 38 / 薬物数 : 38 - (DrugBank : 15) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 118
| 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 | NCT02432560 (ClinicalTrials.gov) | March 2015 | 4/3/2015 | Safety and Durability of Sirolimus for Treatment of LAM | Multicenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS) | Lymphangioleiomyomatosis | Drug: Sirolimus;Drug: Everolimus | University of Cincinnati | Rare Diseases Clinical Research Network;National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);The LAM Foundation | Recruiting | 18 Years | N/A | Female | 600 | United States | |
| 2 | NCT02061397 (ClinicalTrials.gov) | March 2014 | 23/1/2014 | Safety of Simvastatin in LAM and TSC | The Safety of Simvastatin (SOS) in Patients With Pulmonary Lymphangioleiomyomatosis (LAM) and With Tuberous Sclerosis Complex (TSC) | Lymphangioleiomyomatosis;Tuberous Sclerosis Complex | Drug: Simvastatin;Drug: Sirolimus Oral Product;Drug: Everolimus Oral Product | University of Pennsylvania | The LAM Foundation | Completed | 18 Years | N/A | Female | 10 | Phase 1/Phase 2 | United States |
| 3 | EUCTR2010-019825-32-IT (EUCTR) | 28/07/2010 | 18/05/2010 | An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients with Lymphangioleiomyomatosis. - ND | An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients with Lymphangioleiomyomatosis. - ND | Lymphangioleiomyomatosis MedDRA version: 12.1;Level: LLT;Classification code 10049459;Term: Lymphangioleiomyomatosis | INN or Proposed INN: Everolimus INN or Proposed INN: Everolimus INN or Proposed INN: Everolimus | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: no | 24 | France;Italy | |||
| 4 | EUCTR2010-019825-32-FR (EUCTR) | 29/06/2010 | 28/05/2010 | An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients withLymphangioleiomyomatosis | An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients withLymphangioleiomyomatosis | Lymphangioleiomyomatosis MedDRA version: 12.1;Level: LLT;Classification code 10049459;Term: Lymphangioleiomyomatosis | Product Code: RAD001 INN or Proposed INN: everolimus Trade Name: Afinitor Product Code: RAD001 INN or Proposed INN: everolimus Trade Name: Afinitor Product Code: RAD001 INN or Proposed INN: everolimus | Novartis Pharma Service AG | NULL | Not Recruiting | Female: yes Male: no | 24 | France;Italy | |||
| 5 | EUCTR2008-002113-48-NL (EUCTR) | 16/03/2010 | 02/04/2009 | A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) | A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) | Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) MedDRA version: 9.1;Level: LLT;Classification code 10051810;Term: Angiomyolipoma | Product Name: RAD001 Product Code: RAD001 INN or Proposed INN: EVEROLIMUS | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 99 | France;Spain;Germany;Netherlands;Italy;United Kingdom | |||
| 6 | NCT01059318 (ClinicalTrials.gov) | January 2010 | 28/1/2010 | A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis | An Exploratory, Open-label, Non-randomized, Within-patient Multiple Dose-escalation Safety, Tolerability, PK and Efficacy Trial of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis | Lymphangioleiomyomatosis | Drug: Everolimus | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | Female | 24 | Phase 2 | United States;France;Italy;Germany |
| 7 | EUCTR2008-002113-48-IT (EUCTR) | 03/09/2009 | 07/09/2009 | A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - ND | A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - ND | Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) MedDRA version: 12.0;Level: LLT;Classification code 10051810;Term: Angiomyolipoma | Product Name: RAD001 Product Code: RAD001 INN or Proposed INN: Everolimus | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 99 | France;Spain;Netherlands;Germany;United Kingdom;Italy | |||
| 8 | EUCTR2008-002113-48-GB (EUCTR) | 06/08/2009 | 22/05/2009 | Efficacy and Safety of RAD001 in patients aged 18 and over with Angiomyolipoma associated with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) | A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - EXIST-2 | Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) MedDRA version: 17.0;Level: PT;Classification code 10051810;Term: Angiomyolipoma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Trade Name: Afinitor 5mg Tablets Product Name: RAD001 Product Code: RAD001 INN or Proposed INN: Everolimus | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 118 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;Japan;United Kingdom | ||
| 9 | NCT00790400 (ClinicalTrials.gov) | April 2009 | 10/11/2008 | Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) | A Randomized, Double-blind, Placebo-controlled Study of RAD0001 in the Treatment of Angiomyolipoma in Patients With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) | Tuberous Sclerosis Complex (TSC);Lymphangioleiomyomatosis (LAM) | Drug: Everolimus (RAD001);Drug: Everolimus Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 118 | Phase 3 | United States;Canada;France;Germany;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;United Kingdom |
| 10 | EUCTR2008-002113-48-FR (EUCTR) | 18/03/2009 | 19/03/2009 | A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) | A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) | Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) MedDRA version: 9.1;Level: LLT;Classification code 10051810;Term: Angiomyolipoma | Product Name: RAD001 Product Code: RAD001 INN or Proposed INN: EVEROLIMUS | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 99 | Phase 3 | France;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 11 | NCT00792766 (ClinicalTrials.gov) | December 2008 | 17/11/2008 | Long Term Follow Up for RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis (TSC) and Sporadic Lymphangioleiomyomatosis (LAM) | Long Term Follow Up for RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis | Tuberous Sclerosis;Angiolipoma | Drug: everolimus (RAD001) | Children's Hospital Medical Center, Cincinnati | Novartis | Completed | 18 Years | 65 Years | Both | 20 | Phase 1/Phase 2 | United States |
| 12 | EUCTR2008-002113-48-DE (EUCTR) | 12/02/2009 | Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) | A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - EXIST-2 | Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) MedDRA version: 16.1;Level: PT;Classification code 10051810;Term: Angiomyolipoma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Afinitor Product Name: RAD001 5mg Product Code: RAD001 INN or Proposed INN: EVEROLIMUS | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 118 | Phase 3 | France;United States;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Japan |