12 completed. 5 Phase 3, 4 Phase 2, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 5 | Completed 5 |
| Phase 2 | 4 | Completed 4 |
| Phase 1 | 3 | Completed 3 |
Follow ISIS 301012: new trials by email Literature Review of ISIS 301012 trials Research Report on ISIS 301012
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 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 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 |
| 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 |
Hypercholesterolemia (7) · Dyslipidemias (5) · Hyperlipidemias (5) · Hyperlipoproteinemia Type II (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)
United States (8) · Canada (5) · Netherlands (3) · South Africa (3) · United Kingdom (3) · Brazil (2) · Germany (2) · Singapore (2) · Taiwan (2) · Czechia (1)
PMID 25614280, PMID 27578134, PMID 20707601, PMID 20008831, PMID 20227758, PMID 22507979, PMID 23060426, PMID 23152839, PMID 24013058, PMID 24366918, PMID 24627419
2005 (3), 2008 (1)