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.

Stopped early · Phase 2/Phase 3

Conditions studied: Atherosclerosis, Heterozygous Familial Hypercholesterolemia

In brief

The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.

Key facts

Study ID

NCT00151788

Run by

Daiichi Sankyo

People needed

796

Starts

2004-02-01

Expected to finish

2006-03-01

Last updated by the study team

2012-01-18

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Santa Ana, California, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States
• Study site — Vancouver, British Columbia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Chicoutimi, Quebec, Canada
• Study site — Chomedey Laval, Quebec, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Ste-Foy, Quebec, Canada
• Study site — Jerusalem, Israel
• Study site — Amsterdam, Zuidoost, Netherlands
• Study site — Capelle aan den IJssel, Netherlands
• Study site — Dordrecht, Netherlands
• Study site — Etten-Leur, Netherlands
• Study site — Goes, Netherlands
• Study site — Gorinchem, Netherlands
• Study site — Gouda, Netherlands
• Study site — Groningen, Netherlands
• Study site — Hoorn, Netherlands
• Study site — Leiden, Netherlands

Full record on ClinicalTrials.gov

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