At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 158 enrolled
Drug / intervention
Mipomersen sodium +1 moredrug
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.
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) as Add-on Therapy in High Risk Hypercholesterolemic Patients
In Brief
A Phase 3 clinical trial evaluating Mipomersen sodium and Placebo for Hypercholesterolemia and Coronary Heart Disease. Completed, enrolled 158 participants across 62 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (CHD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Coronary Heart Disease
CountriesUnited States
CollaboratorsIonis Pharmaceuticals, Inc.
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2008
Enrollment StartNov 2008
Primary CompletionMay 2010
Study CompletionOct 2010
TodayJul 2026
First PostedOct 9, 2008
Enrollment StartNov 1, 2008
Primary CompletionMay 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.7 years ago
Interventions
Mipomersen sodiumdrug
200 mg/mL
Placebodrug
1 mL matching placebo (i.e., vehicle consisting of 9 mg of sodium chloride, 0.004 mg of riboflavin, filled to 1 mL with water).