Lomitapide 2mg hard capsules ( 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)2

79. 家族性高コレステロール血症(ホモ接合体)


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-002278-30-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
2EUCTR2019-002278-30-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;Israel;Tunisia;Germany;Italy