CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 114 enrolled
Drug / intervention
Volanesorsen +1 moredrug
Likely dose
Volanesorsen 300 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/NCT02300233
NCT02300233Phase 3Completed

The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

Ionis Pharmaceuticals, Inc.·interventional·Posted Nov 24, 2014·Updated Apr 13, 2022

In Brief

A Phase 3 clinical trial evaluating Volanesorsen and Placebo for Hypertriglyceridemia. Completed, enrolled 114 participants across 45 sites in 6 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Germany, Netherlands, United Kingdom, United States
CollaboratorsAkcea Therapeutics

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 24, 2014
Enrollment StartFeb 5, 2015
Primary CompletionJul 27, 2016
Study CompletionJan 24, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.6 years ago

Interventions

Volanesorsendrug

300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.

Placebodrug

Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.