Status:
COMPLETED
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-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
To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had...
Detailed Description
All familial hypercholesterolemia (FH) or severe hypercholesterolemia participants who had tolerated the treatment regimen in Protocol 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849) or MIPO3500108...
Eligibility Criteria
Inclusion
- Satisfactory completion of dosing in their initial study (Protocol 301012-CS5 \[NCT00607373\], 301012-CS7 \[NCT00706849\], 301012-CS17 \[NCT00477594\], or MIPO3500108 \[NCT00794664\])
Exclusion
- Had any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00694109
Start Date
April 1 2008
End Date
September 1 2014
Last Update
September 9 2016
Active Locations (33)
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1
Mission Viejo, California, United States, 92691
2
Newport Beach, California, United States, 92660
3
Bridgeport, Connecticut, United States, 06606
4
Melbourne, Florida, United States, 32901