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.

Atherosclerosis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00151788
• Other study ID #: 505-205
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 7, 2005
• Last updated: January 16, 2012
• Start date: February 2004
• Est. completion date: March 2006

Study information

• Verified date: January 2012
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 796
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Heterozygous Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Drug:
• Pactimibe sulfate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the effects of pactimibe versus placebo, when added to usual medical care:
Secondary	- on the incidence and the time to first occurrence of
Secondary	cardiovascular events,
Secondary	- on inflammatory and oxidative markers, such as serum
Secondary	high-sensitivity C-reactive protein (hsCRP), plasma
Secondary	interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and
Secondary	serum nitrotyrosine.
Secondary	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.