Status:
COMPLETED
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Heterozygous Familial Hypercholesterolemia
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH...
Detailed Description
Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder of lipoprotein metabolism characterized by markedly elevated LDL-C, premature onset of atherosclerosis and development of x...
Eligibility Criteria
Inclusion
- Diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)
- Diagnosis of Coronary Artery Disease (CAD)
- Stable lipid-lowering therapy for 12 weeks
- On maximally tolerated statin therapy with at least 1 statin at a dose greater than zero, per Investigator judgment
- Stable low-fat diet for 8 weeks
- Stable weight for 6 weeks
Exclusion
- Significant health problems in recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, orthostatic hypotension, uncontrolled hypertension, blood disorders, liver disease, cancer, or digestive problems
- Receiving apheresis treatment or last apheresis treatment within 8 weeks
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00706849
Start Date
July 1 2008
End Date
May 1 2010
Last Update
September 9 2016
Active Locations (48)
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1
La Jolla, California, United States, 92093
2
Los Angeles, California, United States, 90048
3
Mission Viejo, California, United States, 92691
4
Newport Beach, California, United States, 92260