Status:
TERMINATED
Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Carotid Artery Disease. This Study is Also Known as CAPTIVATE.
Lead Sponsor:
Daiichi Sankyo
Conditions:
Atherosclerosis
Heterozygous Familial Hypercholesterolemia
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.
Eligibility Criteria
Inclusion
- Confirmed diagnosis of heterozygous familial hypercholesterolemia
- Ambulatory male (40 to 75 years, inclusive) or female (45 to 75 years, inclusive) subjects
- Calculated LDL-C level greater than or equal to 100 mg/dL (or 2.5 mmol/L) and triglycerides less than 500 mg/dL (5.65 mmol/L) while on usual and stable lipid-lowering therapy
Exclusion
- Breast feeding or lactating women
- Previous organ transplantation
- High-grade stenosis (\>75%) or the occlusion of any segment of either carotid artery
- History of carotid endarterectomy, or insertion of carotid artery stent or are scheduled to have either of these procedures
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
796 Patients enrolled
Trial Details
Trial ID
NCT00151788
Start Date
February 1 2004
End Date
March 1 2006
Last Update
January 18 2012
Active Locations (37)
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1
Santa Ana, California, United States
2
Chicago, Illinois, United States
3
Baltimore, Maryland, United States
4
St Louis, Missouri, United States