Clinical Trial: The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in patients with Familial Chylomicronemia Syndrome

Detailed Summary:
Sponsor: Ionis Pharmaceuticals, Inc.

Current Primary Outcome: Efficacy of ISIS-APOCIIIRx as measured by the percent change in fasting triglycerides from baseline [ Time Frame: 13 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ionis Pharmaceuticals, Inc.

Dates:
Date Received: August 5, 2014
Date Started: August 2014
Date Completion:
Last Updated: May 1, 2017
Last Verified: May 2017