18 completed. 7 Phase 2, 6 Phase 3, 5 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 7 |
| Phase 3 | 6 | Completed 6 |
| Phase 1 | 5 | Completed 5 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol mipomersen sodium 200 mg, Placebo, mipomersen sodium 70 mg - Hypercholesterolemia, Heterozygous Familial | Phase 3 | Completed | Kastle Therapeutics, LLC | 309 | 2011-12-01 | 2019-03-26 |
| Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects mipomersen, Placebo - Healthy Volunteer | Phase 1 | Completed | Kastle Therapeutics, LLC | 20 | 2011-09-01 | 2016-08-03 |
| A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers mipomersen, placebo - Healthy Volunteer | Phase 1 | Completed | Kastle Therapeutics, LLC | 20 | 2011-01-01 | 2016-08-03 |
| A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin warfarin sodium, mipomersen sodium; warfarin sodium - Healthy | Phase 1 | Completed | Kastle Therapeutics, LLC | 18 | 2010-05-01 | 2016-08-03 |
| A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects mipomersen sodium, moxifloxacin hydrochloride (Avelox®), placebo - Healthy | Phase 1 | Completed | Kastle Therapeutics, LLC | 60 | 2010-03-01 | 2016-08-03 |
| A Study to Evaluate 3 Different Dosing Regimens of Mipomersen Administered Via Subcutaneous Injections to Healthy Volunteers mipomersen, Placebo - Healthy Volunteer | Phase 1 | Completed | Kastle Therapeutics, LLC | 84 | 2010-01-01 | 2016-08-03 |
| Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis Mipomersen, Placebo - Hypercholesterolemia, Coronary Heart Disease | Phase 3 | Completed | Kastle Therapeutics, LLC | 58 | 2009-01-01 | 2016-09-09 |
| Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients Mipomersen sodium, Placebo - Hypercholesterolemia, Coronary Heart Disease | Phase 3 | Completed | Kastle Therapeutics, LLC | 158 | 2008-11-01 | 2016-09-09 |
| Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects mipomersen, placebo - Metabolic Diseases, Hyperlipidemias | Phase 2 | Completed | Kastle Therapeutics, LLC | 34 | 2008-10-01 | 2016-09-09 |
| Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease mipomersen sodium, placebo - Heterozygous Familial Hypercholesterolemia, Coronary Artery Disease | Phase 3 | Completed | Kastle Therapeutics, LLC | 124 | 2008-07-01 | 2016-09-09 |
| An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia Mipomersen Sodium - Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant | Phase 3 | Completed | Kastle Therapeutics, LLC | 144 | 2008-04-01 | 2016-09-09 |
| Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia mipomersen, Placebo - Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant | Phase 3 | Completed | Kastle Therapeutics, LLC | 51 | 2007-07-01 | 2016-09-09 |
| Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia mipomersen sodium - Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant | Phase 2 | Completed | Kastle Therapeutics, LLC | 21 | 2007-05-01 | 2016-09-09 |
| Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration mipomersen, Placebo - Lipid Metabolism, Inborn Errors, Hyperlipidemias | Phase 2 | Completed | Kastle Therapeutics, LLC | 38 | 2006-07-01 | 2016-10-21 |
| Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy ISIS 301012 or Placebo - Hypercholesterolemia, Familial | Phase 2 | Completed | Kastle Therapeutics, LLC | 44 | 2006-02-01 | 2016-08-03 |
| Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy ISIS 301012 - Hypercholesterolemia, Familial | Phase 2 | Completed | Kastle Therapeutics, LLC | 12 | 2006-01-01 | 2016-08-03 |
| Dose-escalating Safety Study in Subjects on Stable Statin Therapy ISIS 301012 or Placebo - Hypercholesterolemia | Phase 2 | Completed | Kastle Therapeutics, LLC | 74 | 2005-09-01 | 2016-08-03 |
| Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels ISIS 301012 or Placebo - Hypercholesterolemia | Phase 2 | Completed | Kastle Therapeutics, LLC | 50 | 2005-08-01 | 2016-08-03 |
Hypercholesterolemia (10) · Hyperlipoproteinemia Type II (6) · Dyslipidemias (5) · Hyperlipidemias (5) · Lipid Metabolism Disorders (5) · Metabolic Diseases (5) · Congenital Abnormalities (4) · Genetic Diseases, Inborn (4) · Homozygous Familial Hypercholesterolemia (4) · Infant, Newborn, Diseases (4) · Lipid Metabolism, Inborn Errors (4) · Metabolism, Inborn Errors (4) · Hyperlipoproteinemias (3) · Coronary Disease (2) · Coronary Artery Disease (1)
mipomersen (18) · Moxifloxacin (1) · Warfarin (1)
United States (13) · Canada (6) · Netherlands (6) · Germany (4) · South Africa (4) · United Kingdom (4) · Brazil (3) · Taiwan (3) · Czechia (2) · Singapore (2) · Argentina (1) · Australia (1) · Belgium (1) · Croatia (1) · Denmark (1)
PMID 25614280, PMID 27578134, PMID 20707601, PMID 20008831, PMID 20227758, PMID 20378080, PMID 21593041, PMID 22507979, PMID 23060426, PMID 23152839, PMID 24013058, PMID 24366918, PMID 24627419, PMID 26946290
2005 (4), 2008 (1)