Phase 3
N=9
Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy
Familial Hypercholesterolemia - Homozygous
Bottom Line
View on ClinicalTrials.gov: NCT02173158 ↗Enrolled (actual)
9
Serious AEs
5.9%
Results posted
Oct 2018
Primary outcome: Primary: Percent Change in LDL-C — -42.2 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- lomitapide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aegerion Pharmaceuticals, Inc.
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in LDL-C |
-42.2 | — |
| SECONDARY Change in Total Cholesterol |
-25.9 | — |
| SECONDARY Change in Apo B |
-41.4 | — |
| SECONDARY Change in Triglycerides |
-44.4 | — |
| SECONDARY Change in Non-HDL-C |
-34.6 | — |
| SECONDARY Change in VLDL-C |
-44.8 | — |
| SECONDARY Change in Lp(a) |
-27.2 | — |
| SECONDARY Change in HDL-C |
5.9 | — |
| SECONDARY Change in Apo AI |
-2.8 | — |
| SECONDARY Change in LDL-C |
-37.5 | — |
Summary
Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.
Eligibility Criteria
Inclusion Criteria
- Japanese male and female patients aged ≥ 18 years of age who are receiving maximally tolerated, stable, lipid-lowering therapy
- Diagnosis of functional HoFH
- Body weight ≥ 40 kg and 10 mg per day
- Documented diagnosis of any liver disease
Data sourced from ClinicalTrials.gov (NCT02173158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.