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.

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00151788
• Collaborator: (none)
• Enrollment: 796
• Locations: 37
• Duration (Months): 24.9
• Patients Per Site: 21.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis; Heterozygous Familial Hypercholesterolemia	Drug: Pactimibe sulfate	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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)
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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

1. To assess the effects of pactimibe versus placebo, when added to usual medical care: []

2. - on the incidence and the time to first occurrence of []

3. cardiovascular events, []

4. - on inflammatory and oxidative markers, such as serum []

5. high-sensitivity C-reactive protein (hsCRP), plasma []

6. interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and []

7. serum nitrotyrosine. []

8. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Santa Ana	California	United States
2		Chicago	Illinois	United States
3		Baltimore	Maryland	United States
4		St. Louis	Missouri	United States
5		Cincinnati	Ohio	United States
6		Houston	Texas	United States
7		Salt Lake City	Utah	United States
8		Seattle	Washington	United States
9		Vancouver	British Columbia	Canada
10		Toronto	Ontario	Canada
11		Chicoutimi	Quebec	Canada
12		Chomedey Laval	Quebec	Canada
13		Montreal	Quebec	Canada
14		Ste-Foy	Quebec	Canada
15		Jerusalem		Israel
16		Amsterdam	Zuidoost	Netherlands
17		Capelle a/d Ijssel		Netherlands
18		Dordrecht		Netherlands
19		Etten-Leur		Netherlands
20		Goes		Netherlands
21		Gorinchem		Netherlands
22		Gouda		Netherlands
23		Groningen		Netherlands
24		Hoorn		Netherlands
25		Leiden		Netherlands
26		Rotterdam		Netherlands
27		Tilburg		Netherlands
28		Oslo		Norway
29		Bellville		South Africa
30		Midrand		South Africa
31		Pretoria		South Africa
32		Barcelona		Spain
33		Cordoba		Spain
34		Linkoping		Sweden
35		Stockholm		Sweden
36		London		United Kingdom
37		Manchester		United Kingdom

Sponsors and Collaborators

• Daiichi Sankyo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo, Inc.
• ClinicalTrials.gov Identifier: NCT00151788
• Other Study ID Numbers: 505-205
• First Posted: Sep 9, 2005
• Last Update Posted: Jan 18, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Atherosclerosis; Hyperlipoproteinemia Type II; Hypercholesterolemia

Study Results

No Results Posted as of Jan 18, 2012