A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy
Phase of Trial: Phase III
Latest Information Update: 16 Oct 2018
At a glance
- Drugs Lomitapide (Primary)
- Indications Hyperlipoproteinaemia type II
- Focus Registrational; Therapeutic Use
- Sponsors Aegerion Pharmaceuticals
- 21 Feb 2018 Status changed from active, no longer recruiting to completed.
- 28 Sep 2016 According to Aegerion Pharmaceuticals media release, based upon the data of this trial, Japan's Ministry of Health, Labor & Welfare (MHLW) has approved JUXTAPID for patients with homozygous familial hypercholesterolemia (HoFH).
- 11 Jan 2016 According to an Aegerion Pharmaceuticals media release, the company has submitted a New Drug Application to the Ministry of Health, Labour and Welfare (MHLW) for marketing approval of JUXTAPID for the treatment of homozygous familial hypercholesterolemia (HoFH) in Japan.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History