At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 21 enrolled
Drug / intervention
mipomersen sodiumdrug
Likely dose
mipomersen sodium 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Extension Study to Assess the Long-term Safety and Efficacy of Mipomersen in Subjects With Familial Hypercholesterolemia
In Brief
A Phase 2 clinical trial evaluating mipomersen sodium for Lipid Metabolism, Inborn Errors and 13 related conditions. Completed, enrolled 21 participants across 5 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases, Hyperlipoproteinemia Type II, Metabolism, Inborn Errors, Genetic Diseases, Inborn, Infant, Newborn, Diseases, Metabolic Disorder, Congenital Abnormalities, Hypercholesterolemia, Hyperlipoproteinemias, Dyslipidemias, Lipid Metabolism Disorders
CountriesUnited States
CollaboratorsIonis Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedMay 2007
Primary CompletionMar 2011
Study CompletionJul 2011
TodayJul 2026
First PostedMay 24, 2007
Enrollment StartMay 1, 2007
Primary CompletionMar 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.1 years ago
Interventions
mipomersen sodiumdrug
200 mg/ml, in 1 ml solution for subcutaneous injection.