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.

Phase 2

Terminated

• Conditions: Atherosclerosis; Heterozygous Familial Hypercholesterolemia

• Registration Number: NCT00151788
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 796

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis.

Secondary Outcome Measures

Name	Time	Method
To assess the effects of pactimibe versus placebo, when added to usual medical care:
- on the incidence and the time to first occurrence of
cardiovascular events,
- on inflammatory and oxidative markers, such as serum
high-sensitivity C-reactive protein (hsCRP), plasma
interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and
serum nitrotyrosine.
To compare the safety of pactimibe versus placebo, when added to usual medical care, particularly with respect to the incidence of clincal and laboratory adverse events.