CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 124 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.

Search/NCT00706849
NCT00706849Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of ISIS 301012 as Add-on Therapy in Heterozygous Familial Hypercholesterolemia Subjects With Coronary Artery Disease

Kastle Therapeutics, LLC·interventional·Posted Jun 30, 2008·Updated Sep 9, 2016

In Brief

A Phase 3 clinical trial evaluating mipomersen sodium and placebo for Heterozygous Familial Hypercholesterolemia and Coronary Artery Disease. Completed, enrolled 124 participants across 48 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable dose of other lipid-lowering agents (including maximally tolerated statin therapy).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeterozygous Familial Hypercholesterolemia, Coronary Artery Disease
CountriesCanada, United States
CollaboratorsIonis Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 30, 2008
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.0 years ago

Interventions

mipomersen sodiumdrug

200 mg /mL

placebodrug

1 mL matching placebo