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.

A Randomized, Double-blind, Stratified, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of the ACAT Inhibitor CS-505 for Reducing the Progression of Atherosclerosis in Subjects With Heterozygous Familial Hypercholesterolemia and Carotid Atherosclerosis Using Carotid Ultrasound (CUS)

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151788

Enrollment

796

Registered

2005-09-09

Start date

2004-02-29

Completion date

2006-03-31

Last updated

2012-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Heterozygous Familial Hypercholesterolemia

Brief summary

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

Interventions

DRUGPactimibe sulfate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- on the incidence and the time to first occurrence of	—
cardiovascular events,	—
- on inflammatory and oxidative markers, such as serum	—
To assess the effects of pactimibe versus placebo, when added to usual medical care:	—
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.	—
high-sensitivity C-reactive protein (hsCRP), plasma	—

Countries

Canada, Israel, Netherlands, Norway, South Africa, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026