Clinical Trial: The BROADEN Study: A Study of Volanesorsen (Formerly ISIS-APOCIIIRx) in Patients With Familial Partial Lipodystrophy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled, With an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients With Familial Partial Lipodys
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of volanesorsen (IONIS-APOCIIIRx) given for 52 weeks in patients with Familial Partial Lipodystrophy.
Detailed Summary:
Sponsor: Ionis Pharmaceuticals, Inc.
Current Primary Outcome: Efficacy of volanesorsen (IONIS-APOCIIIRx) measured as the percent change in fasting triglycerides from baseline. [ Time Frame: 13 weeks ]
Original Primary Outcome: Efficacy of volanesorsen (ISIS-APOCIIIRx) measured as the percent change in fasting triglycerides from baseline. [ Time Frame: 13 weeks ]
Current Secondary Outcome: Change from Baseline in hemoglobin A1c (HbA1c) in patients with diabetes. [ Time Frame: 13 weeks ]
Original Secondary Outcome:
Information By: Ionis Pharmaceuticals, Inc.
Dates:
Date Received: August 17, 2015
Date Started: October 31, 2015
Date Completion:
Last Updated: April 25, 2017
Last Verified: April 2017