At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
mipomersen +1 moredrug
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.
A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of ISIS 301012 Administration in High Risk Statin Intolerant Subjects
In Brief
A Phase 2 clinical trial evaluating mipomersen and placebo for Metabolic Diseases and 5 related conditions. Completed, enrolled 34 participants across 1 site.
Detailed Summary
The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apoB) in high risk subjects intolerant to statins.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Diseases, Hyperlipidemias, Metabolic Disorder, Hypercholesterolemia, Dyslipidemias, Lipid Metabolism Disorders
CountriesNetherlands
CollaboratorsIonis Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartOct 2008
Primary CompletionAug 2010
Study CompletionJan 2011
TodayJul 2026
First PostedJul 1, 2008
Enrollment StartOct 1, 2008
Primary CompletionAug 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.0 years ago
Interventions
mipomersendrug
placebodrug