LOMITAPIDE ( DrugBank: Lomitapide )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
79家族性高コレステロール血症(ホモ接合体)11

79. 家族性高コレステロール血症(ホモ接合体)


臨床試験数 : 142 薬物数 : 114 - (DrugBank : 29) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 18
No.TrialIDDate_
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PhaseCountries
1NCT04681170
(ClinicalTrials.gov)
November 23, 20207/12/2020Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)Phase III, Single Arm, Open Label, International, Multi Centre Study to Evaluate the Efficacy and Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH) on Stable Lipid Lowering TherapyHomozygous Familial Hypercholesterolaemia (HoFH)Drug: LomitapideAmryt PharmaNULLRecruiting5 Years17 YearsAll45Phase 3Germany;Israel;Italy;Saudi Arabia;Spain;Tunisia
2EUCTR2019-002278-30-IT
(EUCTR)
11/11/202021/01/2021A clinical trial to assess the safety and effect of the drug lomitapide in the treatment of children with the condition Homozygous Familial Hypercholesterolaemia (HoFH) who are on Stable Lipid-lowering TherapyPhase III, single-arm, open-label, international, multi-centre study to evaluate the efficacy and safety of lomitapide in paediatric patients with Homozygous Familial Hypercholesterolaemia (HoFH) on stable lipid-lowering therapy - APH-19 Homozygous familial hypercholesterolaemia (HoFH). A rare and life-threatening inherited disorder of lipid metabolism with an estimated prevalence of 1 per 160,000 to 300,000 in the European population.
MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850
MedDRA version: 20.0;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Lojuxta 5 mg hard capsules
Product Name: Lojuxta 5 mg hard capsules
Product Code: [PRD7255830]
INN or Proposed INN: LOMITAPIDE
Trade Name: Lojuxta 10 mg hard capsules
Product Name: Lojuxta 10 mg hard capsules
Product Code: [PRD7255977]
INN or Proposed INN: LOMITAPIDE
Trade Name: Lojuxta 20 mg hard capsules
Product Name: Lojuxta 20 mg hard capsules
Product Code: [PRD7256003]
INN or Proposed INN: LOMITAPIDE
Product Name: Lomitapide 2mg hard capsules
Product Code: [Lomitapide 2mg hard capsules]
INN or Proposed INN: LOMITAPIDE
Amryt Pharmaceuticals DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 3Saudi Arabia;Spain;Turkey;Israel;Germany;Tunisia;Italy
3EUCTR2019-002278-30-DE
(EUCTR)
12/08/202011/09/2019A clinical trial to assess the safety and effect of the drug lomitapide in the treatment of children with the condition Homozygous Familial Hypercholesterolaemia (HoFH) who are on Stable Lipid-lowering TherapyPhase III, single-arm, open-label, international, multi-centre study to evaluate the efficacy and safety of lomitapide in paediatric patients with Homozygous Familial Hypercholesterolaemia (HoFH) on stable lipid-lowering therapy Homozygous familial hypercholesterolaemia (HoFH). A rare and life-threatening inherited disorder of lipid metabolism with an estimated prevalence of 1 per 160,000 to 300,000 in the European population.
MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Lojuxta 5 mg hard capsules
INN or Proposed INN: LOMITAPIDE
Trade Name: Lojuxta 10 mg hard capsules
INN or Proposed INN: LOMITAPIDE
Trade Name: Lojuxta 20 mg hard capsules
INN or Proposed INN: LOMITAPIDE
Product Name: Lomitapide 2mg hard capsules
INN or Proposed INN: LOMITAPIDE
Amryt Pharmaceuticals DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 3Saudi Arabia;Spain;Turkey;Israel;Tunisia;Germany;Italy
4EUCTR2014-003806-33-GR
(EUCTR)
30/06/201624/03/2016A 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.NULLNot RecruitingFemale: yes
Male: yes
45Phase 3Canada;Greece;Turkey;Austria;Israel;Germany;Italy
5NCT02765841
(ClinicalTrials.gov)
May 201627/4/2016Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering TherapyA 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 TherapyHomozygous Familial HypercholesterolemiaDrug: LomitapideAegerion Pharmaceuticals, Inc.NULLWithdrawn5 Years17 YearsAll0Phase 3NULL
6NCT02399852
(ClinicalTrials.gov)
June 201523/3/2015Effects of Lomitapide on Carotid and Aortic AtherosclerosisEffects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)Homozygous Familial HypercholesterolemiaDrug: LomitapideAegerion Pharmaceuticals, Inc.NULLWithdrawn18 YearsN/AAll0N/ANULL
7NCT02173158
(ClinicalTrials.gov)
April 2, 201423/6/2014Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering TherapyA Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering TherapyFamilial Hypercholesterolemia - HomozygousDrug: lomitapideAegerion Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll9Phase 3Japan
8NCT02135705
(ClinicalTrials.gov)
March 18, 201410/4/2014LOWER: Lomitapide Observational Worldwide Evaluation RegistryLOWER: Lomitapide Observational Worldwide Evaluation RegistryHomozygous Familial HypercholesterolemiaDrug: LomitapideAmryt PharmaNULLRecruiting18 YearsN/AAll300United States
9EUCTR2010-023742-79-IT
(EUCTR)
25/03/201121/02/2011A 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 - NDA 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 PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
23Phase 3Italy
10NCT00943306
(ClinicalTrials.gov)
October 29, 200921/7/2009Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial HypercholesterolemiaA Phase III, Long Term, Open Label, Follow on Study of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor 'Lomitapide' (LOMITAPIDE) in Patients With Homozygous Familial HypercholesterolemiaFamilial HypercholesterolemiaDrug: lomitapideAegerion Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll19Phase 3United States;Canada;Italy;South Africa
11NCT01556906
(ClinicalTrials.gov)
June 20037/3/2012Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) InhibitorA Phase II Open Label, Dose-Escalation Study to Determine the Safety, Tolerability and Efficacy of Microsomal Triglyceride Transfer Protein (MTP) Inhibitor BMS-201038 in Patients With Homozygous Familial HypercholeterolemiaHomozygous Familial HypercholesterolemiaDrug: LomitapideAegerion Pharmaceuticals, Inc.University of Pennsylvania;Doris Duke Charitable FoundationCompleted13 YearsN/AAll6Phase 2United States