At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 58 enrolled
Drug / intervention
Mipomersen +1 moredrug
Likely dose
Mipomersen 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 Prospective Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis
In Brief
A Phase 3 clinical trial evaluating Mipomersen and Placebo for Hypercholesterolemia and Coronary Heart Disease. Completed, enrolled 58 participants across 27 sites in 6 countries.
Detailed Summary
The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Coronary Heart Disease
CountriesCanada, Czechia, Germany, South Africa, United Kingdom, United States
CollaboratorsIonis Pharmaceuticals, Inc.
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartJan 2009
Primary CompletionMay 2010
Study CompletionOct 2010
TodayJul 2026
First PostedNov 20, 2008
Enrollment StartJan 1, 2009
Primary CompletionMay 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.6 years ago
Interventions
Mipomersendrug
200 mg (1 mL), weekly subcutaneous injections for 26 weeks
Placebodrug
1 mL weekly subcutaneous injections for 26 weeks