Status:
COMPLETED
Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Hypercholesterolemia
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a...
Detailed Description
Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL). Elevated LDL is a major risk factor for CHD. Mipomersen is an antisense drug that reduces a protein in the l...
Eligibility Criteria
Inclusion
- Diagnosis of hypercholesterolemia (LDL-C ≥ 100 mg/dL)
- At high risk of CHD
- On stable, maximally tolerated statin therapy for 8 weeks
- On stable, low fat diet for 12 weeks
- 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, liver disease, cancer, type I diabetes.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00770146
Start Date
November 1 2008
End Date
October 1 2010
Last Update
September 9 2016
Active Locations (62)
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1
Birmingham, Alabama, United States, 35209
2
Birmingham, Alabama, United States, 35294
3
Huntsville, Alabama, United States, 35801
4
Muscle Shoals, Alabama, United States, 35662