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

Coronary Heart Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185042
• Other study ID #: 505-202
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: September 10, 2007
• Start date: November 2002
• Est. completion date: July 2005

Study information

• Verified date: September 2007
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Standard:

1. Male or female subjects, age 18 years or greater; and

2. Diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography.

Angiographic:

1. Evidence of coronary heart disease

2. Identification of a target native coronary artery for the plaque volume measurement.

Exclusion Criteria:

Standard:

1. Breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months;

2. Previous heart or other organ transplantation;

3. 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.

4. 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.

5. Stroke (CVA) within previous 3 months;

6. Evidence of severe symptomatic heart failure (NYHA Class III or IV) or known ejection fraction less than 30%;

7. Uncontrolled diabetes mellitus;

8. Uncontrolled hypertension; and

9. Nephrotic syndrome, significant nephropathy, or other significant renal disease.

Angiographic:

1. Presence of any lesion with greater than 50% reduction in lumen diameter; or

2. Any lesion with a greater than 50% occlusion in the left main coronary artery;

3. 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);

4. A target vessel that is itself a bypass graft.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Pactimibe, CS-505

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare the effect of CS-505 versus placebo when added to usual medical care on:
Secondary	- change from baseline in total atheroma volume in
Secondary	various arteries;
Secondary	- changes in minimum luminal diameter and percent
Secondary	diameter stenosis;
Secondary	- incidence and time to first occurrence of
Secondary	cardiovascular events.
Secondary	To compare the safety of CS-505 versus placebo