Status:
COMPLETED
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Lipid Metabolism, Inborn Errors
Hypercholesterolemia, Autosomal Dominant
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy. This study consisted ...
Detailed Description
Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder of lipoprotein metabolism characterized by markedly elevated low density lipoprotein (LDL), premature onset of atherosclero...
Eligibility Criteria
Inclusion
- Diagnosis of Homozygous Familial Hypercholesterolemia (HoFH)
- Stable lipid-lowering therapy for 12 weeks
- Stable weight for 6 weeks
- Stable low fat diet for 8 weeks
Exclusion
- Significant health problems in the recent past including heart attack, stroke, blood disorders, cancer, or digestive problems
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00607373
Start Date
July 1 2007
End Date
March 1 2009
Last Update
September 9 2016
Active Locations (10)
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1
Charlotte, North Carolina, United States, 28204
2
Cincinnati, Ohio, United States, 45212
3
São Paulo, São Paulo, Brazil, 05403-000
4
Chicoutimi, Quebec, Canada, G7H 5H6