Status:
COMPLETED
Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Metabolic Diseases
Hyperlipidemias
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apoB...
Detailed Description
In humans, apoB is the principal apolipoprotein of the atherogenic lipoproteins, comprising very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL) and low density lipoprotein (LDL...
Eligibility Criteria
Inclusion
- Diagnosis of statin intolerance
- Diagnosis of Coronary Artery Disease (CAD)
- Diagnosis of hypercholesterolemia
- Stable weight for \> 6 weeks
Exclusion
- Significant health problems in the recent past (≤24 weeks) including heart attack, heart surgery, heart failure, uncontrolled hypothyroidism, blood disorders, digestive problems, disease of central nervous system, cancer, liver or renal disease
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00707746
Start Date
October 1 2008
End Date
January 1 2011
Last Update
September 9 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Amsterdam, Netherlands, 1105AZ