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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR MIPOMERSEN SODIUM

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Clinical Trials for Mipomersen Sodium

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

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Clinical Trial Conditions for Mipomersen Sodium

Condition Name

Condition Name for Mipomersen Sodium
Intervention Trials
Hypercholesterolemia 7
Metabolic Disorder 5
Metabolic Diseases 5
Lipid Metabolism Disorders 5
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Condition MeSH

Condition MeSH for Mipomersen Sodium
Intervention Trials
Hypercholesterolemia 8
Disease 5
Hyperlipidemias 5
Metabolic Diseases 5
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Clinical Trial Locations for Mipomersen Sodium

Trials by Country

Trials by Country for Mipomersen Sodium
Location Trials
United States 73
Canada 12
United Kingdom 4
South Africa 3
Netherlands 2
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Trials by US State

Trials by US State for Mipomersen Sodium
Location Trials
Ohio 6
Illinois 4
Texas 4
Missouri 4
Massachusetts 4
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Clinical Trial Progress for Mipomersen Sodium

Clinical Trial Phase

Clinical Trial Phase for Mipomersen Sodium
Clinical Trial Phase Trials
Phase 3 5
Phase 2 3
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Mipomersen Sodium
Clinical Trial Phase Trials
Completed 9
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Clinical Trial Sponsors for Mipomersen Sodium

Sponsor Name

Sponsor Name for Mipomersen Sodium
Sponsor Trials
Kastle Therapeutics, LLC 9
Ionis Pharmaceuticals, Inc. 9
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Sponsor Type

Sponsor Type for Mipomersen Sodium
Sponsor Trials
Industry 18
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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Medtronic
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Teva
Chubb
Express Scripts
Julphar
Cantor Fitzgerald
Argus Health

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