Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02765841

Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy

Homozygous Familial Hypercholesterolemia Clinical Trial

Official title:
A Phase 3, Single-arm, Open-label, International, Multi-center Study to Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy

Clinical Trial Summary

This is a Phase 3 single-arm, open-label, international, multi-center clinical trial to evaluate the efficacy and safety of lomitapide in pediatric patients with HoFH who are receiving stable lipid-lowering therapy, including LDL apheresis. The study is comprised of a 12-week Run-in Period, a primary 24-week Efficacy Phase, followed by an 80-week Safety Phase.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02765841
Study type Interventional
Source Aegerion Pharmaceuticals, Inc.
Contact
Status Withdrawn
Phase Phase 3
Start date May 2016
Completion date December 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT04031742 - A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia Phase 2/Phase 3
Not yet recruiting NCT06009393 - Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia Phase 2
Completed NCT03156621 - Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) Phase 3
Recruiting NCT06125847 - NGGT006 Gene Therapy for Homozygous Familial Hypercholesterolemia Early Phase 1
Completed NCT01878604 - Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia N/A
Completed NCT01412034 - Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects Phase 2
Completed NCT03933293 - A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH Phase 2
Completed NCT00704535 - Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
Recruiting NCT02135705 - LOWER: Lomitapide Observational Worldwide Evaluation Registry
Completed NCT03409744 - Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia Phase 3
Completed NCT04233918 - Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia Phase 3
Withdrawn NCT02399852 - Effects of Lomitapide on Carotid and Aortic Atherosclerosis N/A
Terminated NCT01841684 - Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042) Phase 3
Recruiting NCT01109368 - The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository
Completed NCT01556906 - Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor Phase 2
Active, not recruiting NCT03135184 - HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia N/A
Recruiting NCT04815005 - HoFH, the International Clinical Collaborators Registry
Completed NCT03399786 - Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia Phase 3
Completed NCT03851705 - A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) Phase 3
Completed NCT02265952 - Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH) Phase 2