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.

• Status: Terminated
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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