Trials / Withdrawn
WithdrawnNCT02765841
Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy
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
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Aegerion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lomitapide |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2017-03-01
- Completion
- 2019-12-01
- First posted
- 2016-05-09
- Last updated
- 2018-02-22
Source: ClinicalTrials.gov record NCT02765841. Inclusion in this directory is not an endorsement.