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CLINICAL TRIALS PROFILE FOR MIPOMERSEN SODIUM

Clinical Trials for Mipomersen Sodium

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00362180	Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration	Completed	Ionis Pharmaceuticals, Inc.	Phase 2	This study will assess what, if any, effect that ISIS 301012 (mipomersen) has on liver triglyceride content in multiple groups of subjects with varying degrees of risk for hepatic steatosis. In order to enroll subject groups with varying degrees of risk, the study has included multiple cohorts (Cohorts A-G). Additions and removal of cohorts has been accomplished with protocol amendments.
NCT00362180	Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration	Completed	Kastle Therapeutics, LLC	Phase 2	This study will assess what, if any, effect that ISIS 301012 (mipomersen) has on liver triglyceride content in multiple groups of subjects with varying degrees of risk for hepatic steatosis. In order to enroll subject groups with varying degrees of risk, the study has included multiple cohorts (Cohorts A-G). Additions and removal of cohorts has been accomplished with protocol amendments.
NCT00477594	Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia	Completed	Ionis Pharmaceuticals, Inc.	Phase 2	The purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) clinical drug trials.
NCT00477594	Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia	Completed	Kastle Therapeutics, LLC	Phase 2	The purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) clinical drug trials.
NCT00607373	Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia	Completed	Ionis Pharmaceuticals, Inc.	Phase 3	The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy. This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Following treatment and Week 28 evaluations, participants could elect to enroll in an open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or elected not to enroll in the open-label extension study or who discontinued during the 28-week treatment period were followed in this study for 24 weeks from administration of the last dose of study drug.
NCT00607373	Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia	Completed	Kastle Therapeutics, LLC	Phase 3	The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy. This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Following treatment and Week 28 evaluations, participants could elect to enroll in an open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or elected not to enroll in the open-label extension study or who discontinued during the 28-week treatment period were followed in this study for 24 weeks from administration of the last dose of study drug.
Trial ID	Title	Status	Sponsor	Phase	Summary