Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery Disease

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00185042

Collaborator

(none)

534

Enrollment

Locations

Duration (Months)

11.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to learn if CS-505 is safe and effective for slowing down or possibly reversing the buildup of tissue, cells and fatty deposits (plaque) in the blood vessels of the heart (coronary artery atherosclerosis).

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Drug: Pactimibe, CS-505	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

534 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, 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 Coronary Artery Disease Using Intravascular Ultrasound (IVUS)

Study Start Date :

Nov 1, 2002

Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

To compare the effect of CS-505 versus placebo when added to usual medical care on the change from baseline in percent atheroma volume, as measured by intravascular ultrasound (IVUS) of the identified target coronary artery segment []

Secondary Outcome Measures

To compare the effect of CS-505 versus placebo when added to usual medical care on: []
- change from baseline in total atheroma volume in []
various arteries; []
- changes in minimum luminal diameter and percent []
diameter stenosis; []
- incidence and time to first occurrence of []
cardiovascular events. []
To compare the safety of CS-505 versus placebo []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Standard:

Male or female subjects, age 18 years or greater; and
Diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography.

Angiographic:

Evidence of coronary heart disease
Identification of a target native coronary artery for the plaque volume measurement.

Exclusion Criteria:

Standard:

Breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months;
Previous heart or other organ transplantation;
Treatment with any of the following agents within 4 weeks prior to randomization:

Immunosuppressive agents (cyclosporine, azathioprine);
Rifampin; and
Phenytoin, phenobarbital, valproic acid, or other anticonvulsants.

Any of the following manifestations of cardiac disease:

Myocardial infarction or unstable angina within 24 hours prior to randomization or clinically unstable;
Clinically significant heart disease; and
Coronary artery bypass surgery within previous 3 months.

Stroke (CVA) within previous 3 months;
Evidence of severe symptomatic heart failure (NYHA Class III or IV) or known ejection fraction less than 30%;
Uncontrolled diabetes mellitus;
Uncontrolled hypertension; and
Nephrotic syndrome, significant nephropathy, or other significant renal disease.

Angiographic:

Presence of any lesion with greater than 50% reduction in lumen diameter; or
Any lesion with a greater than 50% occlusion in the left main coronary artery;
A target vessel, including any of its branches, that has undergone or will be undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI);
A target vessel that is itself a bypass graft.

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Huntsville	Alabama	United States
3	Mobile	Alabama	United States
4	Phoenix	Arizona	United States
5	Los Angeles	California	United States
6	San Diego	California	United States
7	Fort Collins	Colorado	United States
8	Bridgeport	Connecticut	United States
9	Newark	Delaware	United States
10	Clearwater	Florida	United States
11	Gainsville	Florida	United States
12	Hudson	Florida	United States
13	Jacksonville	Florida	United States
14	Melbourne	Florida	United States
15	Miami	Florida	United States
16	Pensacola	Florida	United States
17	Port Charlotte	Florida	United States
18	Sarasota	Florida	United States
19	Tallahassee	Florida	United States
20	Tampa	Florida	United States
21	Atlanta	Georgia	United States
22	Springfield	Illinois	United States
23	Louisville	Kentucky	United States
24	Baltimore	Maryland	United States
25	Springfield	Massachusetts	United States
26	Grand Rapids	Michigan	United States
27	Kalamazoo	Michigan	United States
28	Duluth	Minnesota	United States
29	Minneapolis	Minnesota	United States
30	Kansas City	Missouri	United States
31	Lincoln	Nebraska	United States
32	New York	New York	United States
33	Rochester	New York	United States
34	Troy	New York	United States
35	Charlotte	North Carolina	United States
36	Greenville	North Carolina	United States
37	High Point	North Carolina	United States
38	Winston-Salem	North Carolina	United States
39	Akron	Ohio	United States
40	Cleveland	Ohio	United States
41	Elyria	Ohio	United States
42	Mansfield	Ohio	United States
43	Oklahoma City	Oklahoma	United States
44	Doylestown	Pennsylvania	United States
45	Memphis	Tennessee	United States
46	San Antonio	Texas	United States