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

• Status: Completed
• Trial end date: 2015-12-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aegerion Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Japanese male and female patients aged ≥ 18 years of age who are receiving maximally tolerated, stable, lipid-lowering therapy

2. Diagnosis of functional HoFH

3. Body weight ≥ 40 kg and < 136 kg

4. Negative pregnancy test at screening

Exclusion Criteria:

1. Uncontrolled hypertension

2. History of chronic renal insufficiency

3. History of biopsy proven cirrhosis or abnormal liver function tests (LFTs) at screening

4. Any major surgical procedure occurring < 3 months prior to the screening visit

5. Cardiac insufficiency

6. Previous organ transplantation

7. History of a non-skin malignancy within the previous 3 years

8. Patients who are not able to limit their alcohol intake

9. Participation in an investigational drug study within 6 weeks prior to the screening visit

10. Known significant gastrointestinal bowel disease

11. Nursing mothers

12. Serious or unstable medical or psychological conditions

13. Requirement for certain prohibited medications known to be potentially hepatotoxic

14. Use of strong or moderate inhibitors of CYP3A4

15. Use of simvastatin at doses >10 mg per day

16. Documented diagnosis of any liver disease