ISIS 301012 ( DrugBank: - )


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)3

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_
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agemin
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PhaseCountries
1EUCTR2005-003449-15-GB
(EUCTR)
12/07/200709/03/2007A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ISIS 301012 as Add-on Therapy in Homozygous Familial Hypercholesterolemia SubjectsA Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ISIS 301012 as Add-on Therapy in Homozygous Familial Hypercholesterolemia Subjects - RADICHOL I Reduction of low density lipoprotein C (LDL-C) in Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 9.1;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia
Product Name: ISIS 301012
Product Code: ISIS 301012
Other descriptive name: ISIS 301012 phosphorothioate oligonucleotide
Genzyme Europe B.V.NULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
2NCT00607373
(ClinicalTrials.gov)
July 200722/1/2008Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial HypercholesterolemiaA Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Mipomersen as Add-on Therapy in Homozygous Familial Hypercholesterolemia SubjectsLipid Metabolism, Inborn Errors;Hypercholesterolemia, Autosomal Dominant;Hyperlipidemias;Metabolic Diseases;Hyperlipoproteinemia Type II;Metabolism, Inborn Errors;Genetic Diseases, Inborn;Infant, Newborn, Diseases;Metabolic Disorder;Congenital Abnormalities;Hypercholesterolemia;Hyperlipoproteinemias;Dyslipidemias;Lipid Metabolism DisordersDrug: mipomersen;Drug: PlaceboKastle Therapeutics, LLCIonis Pharmaceuticals, Inc.Completed12 YearsN/AAll51Phase 3United States;Brazil;Canada;Singapore;South Africa;Taiwan;United Kingdom;Netherlands
3NCT00280995
(ClinicalTrials.gov)
January 200620/1/2006Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering TherapyA Phase 2, Open-Label, Dose Escalation Study to Assess the Safety and Efficacy of ISIS 301012 as Add-on Therapy in Homozygous Familial Hypercholesterolemia SubjectsHypercholesterolemia, FamilialDrug: ISIS 301012Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.Completed18 YearsN/ABoth12Phase 2United States;Netherlands