79. 家族性高コレステロール血症（ホモ接合体） Homozygous familial hypercholesterolemia Clinical trials / Disease details
臨床試験数 : 145 / 薬物数 : 114 - (DrugBank : 26) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 17
| 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 | EUCTR2014-003806-33-GR (EUCTR) | 30/06/2016 | 24/03/2016 | A clinical study in Pediatric Patients with Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy conducted to assess safety, tolerability and efficacy of Lomitapide | A Phase 3, Single-arm, Open-label, International, Multi-center Study to Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients with Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy | Homozygous familial hypercholesterolemia (HoFH). MedDRA version: 18.1;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: lomitapide Product Code: AEGR-733 INN or Proposed INN: LOMITAPIDE Product Name: lomitapide Product Code: AEGR-733 INN or Proposed INN: LOMITAPIDE Product Name: lomitapide Product Code: AEGR-733 INN or Proposed INN: LOMITAPIDE Product Name: lomitapide Product Code: AEGR-733 INN or Proposed INN: LOMITAPIDE | Aegerion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 3 | Canada;Greece;Turkey;Austria;Israel;Germany;Italy | ||
| 2 | EUCTR2010-023742-79-IT (EUCTR) | 25/03/2011 | 21/02/2011 | A Phase III, Long Term, Open Label, Follow on Study of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor ‘lomitapide’ (AEGR-733) in Patients with Homozygous Familial Hypercholesterolemia - ND | A Phase III, Long Term, Open Label, Follow on Study of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor ‘lomitapide’ (AEGR-733) in Patients with Homozygous Familial Hypercholesterolemia - ND | Homozygous Familial Hypercholesterolemia MedDRA version: 9.1;Level: LLT;Classification code 10057080 | Product Name: Lomitapide Product Code: AEGR-733 Product Name: Lomitapide Product Code: AEGR-733 | AEGERION PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 23 | Phase 3 | Italy | ||
| 3 | EUCTR2008-007058-36-IT (EUCTR) | 25/06/2009 | 03/06/2009 | A Phase III Study of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor AEGR-733 in Patients with Homozygous Familial Hypercholesterolemia on Current Lipid-lowering Therapy - ND | A Phase III Study of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor AEGR-733 in Patients with Homozygous Familial Hypercholesterolemia on Current Lipid-lowering Therapy - ND | Homozygous Familial Hypercholesterolemia MedDRA version: 9.1;Level: LLT;Classification code 10048373;Term: Hypercholesterolaemia aggravated | Product Code: AEGR-733 Product Code: AEGR-733 | Aegerion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 3 | Italy | ||
| 4 | NCT00730236 (ClinicalTrials.gov) | December 2007 | 6/8/2008 | A Safety and Efficacy Study of AEGR-733 to Treat Homozygous Familial Hypercholesterolemia (FH) | A Phase III Study of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor AEGR-733 in Patients With Homozygous Familial Hypercholesterolemia on Current Lipid-lowering Therapy | Homozygous Familial Hypercholesterolemia | Drug: AEGR-733 | Aegerion Pharmaceuticals, Inc. | FDA Office of Orphan Products Development | Completed | 18 Years | N/A | All | 29 | Phase 3 | United States;Canada;Italy;South Africa |