At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 144 enrolled
Drug / intervention
Mipomersen Sodiumdrug
Likely dose
Not stated in 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 ISIS 301012 in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
In Brief
A Phase 3 clinical trial evaluating Mipomersen Sodium for Lipid Metabolism, Inborn Errors and 13 related conditions. Completed, enrolled 144 participants across 33 sites in 7 countries.
Detailed Summary
To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) 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
CountriesBrazil, Canada, Singapore, South Africa, Taiwan, United Kingdom, United States
CollaboratorsIonis Pharmaceuticals, Inc.
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedJun 2008
Primary CompletionSep 2014
TodayJul 2026
First PostedJun 10, 2008
Enrollment StartApr 1, 2008
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 18.1 years ago
Interventions
Mipomersen Sodiumdrug
Subcutaneous injection as a single injection directly into the abdomen, thigh, or outer area of the upper arm.