Status:
COMPLETED
A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
Lead Sponsor:
Kastle Therapeutics, LLC
Conditions:
Hypercholesterolemia
Heterozygous Familial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined ...
Detailed Description
The study consisted of a Screening period of up to 4 weeks, Blinded Treatment Phase of 60 weeks, Open-Label Continuation Period of 26 weeks, and Post-Treatment Phase of 24 weeks. Study Design, maskin...
Eligibility Criteria
Inclusion
- Diagnosis of severe hypercholesterolemia (LDL-C ≥300 mg/dL (7.77 mmol/L) or LDL-C ≥200 mg/dL (5.18 mmol/L) with documented coronary heart disease (CHD) or CHD risk equivalents, or diagnosis of Heterozygous Familial Hypercholesterolemia and LDL-C ≥160 mg/dL (4.14 mmol/L) and \<200 mg/dL (5.18 mmol/L))
- On stable, maximally tolerated, statin therapy for at least 12 weeks or if statin intolerant, on at least 1 medication from another class of hypolipidemic agents (i.e., bile acid sequestrants, niacin/nicotinic acid, cholesterol absorption inhibitors, fibrates).
- On stable, low fat diet for 12 weeks
- Body mass index (BMI) ≤40 kg/m2 and stable weight for \> 6 weeks
Exclusion
- Significant health problems in the recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, hypertension, blood disorders, liver disease, cancer, digestive disorders, Type I diabetes, or uncontrolled Type II diabetes
- Apheresis within 3 months prior to Screening or expected to start apheresis during the treatment phase
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2015
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT01475825
Start Date
December 1 2011
End Date
December 29 2015
Last Update
March 26 2019
Active Locations (113)
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1
Mission Viejo, California, United States
2
Aurora, Colorado, United States
3
Cooper City, Florida, United States
4
Winter Park, Florida, United States