Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy

Familial Hypercholesterolemia - Homozygous Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.

Clinical Trial Description

This is a Phase 3, single-arm, open-label, multicenter clinical trial to evaluate both the efficacy and long-term safety of lomitapide in Japanese patients with HoFH receiving maximally-tolerated, stable lipid-lowering therapy. This study is comprised of a run-in period, a primary 26-week Efficacy Phase, and a 30-week Safety Phase. ;

Related Conditions & MeSH terms

• Familial Hypercholesterolemia - Homozygous
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

• NCT number: NCT02173158
• Study type: Interventional
• Source: Aegerion Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: April 2, 2014
• Completion date: December 17, 2015