CLINICAL TRIALS PROFILE FOR MIPOMERSEN SODIUM
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All Clinical Trials for Mipomersen Sodium
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00362180 ↗ | Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration | Completed | Ionis Pharmaceuticals, Inc. | Phase 2 | 2006-07-01 | 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 | 2006-07-01 | 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 | 2007-05-01 | 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 | 2007-05-01 | 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 | 2007-07-01 | 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 | 2007-07-01 | 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 | >Start Date | >Summary |
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