Status:
COMPLETED
Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia
Lead Sponsor:
Aegerion Pharmaceuticals, Inc.
Conditions:
Familial Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a long term follow on study to assess the continued long term safety and efficacy of lomitapide in patients with homozygous familial hypercholesterolemia.
Detailed Description
This was a phase III open label clinical trial to evaluate the long-term efficacy and safety of lomitapide at the maximum tolerated dose (for each patient) established during the clinical trial 733-00...
Eligibility Criteria
Inclusion
- Completed UP1002 or 733-005.
- Willing and able to provide consent and comply with the requirements of the study protocol.
Exclusion
- Met any of the stopping rules for study discontinuation at the final visit of study UP1002 or 733-005.
Key Trial Info
Start Date :
October 29 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00943306
Start Date
October 29 2009
End Date
December 1 2014
Last Update
June 13 2018
Active Locations (10)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Robarts Research Institute
London, Ontario, Canada, N6A 5K8
4
Lipid Clinic and University of Montreal Community Genomic Medicine Center
Chicoutimi, Quebec, Canada, G7H 5H6