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

September 10, 2007 updated by: Daiichi Sankyo, Inc.

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

534

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Huntsville, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Los Angeles, California, United States
      • San Diego, California, United States
    • Colorado
      • Fort Collins, Colorado, United States
    • Connecticut
      • Bridgeport, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
    • Florida
      • Clearwater, Florida, United States
      • Gainsville, Florida, United States
      • Hudson, Florida, United States
      • Jacksonville, Florida, United States
      • Melbourne, Florida, United States
      • Miami, Florida, United States
      • Pensacola, Florida, United States
      • Port Charlotte, Florida, United States
      • Sarasota, Florida, United States
      • Tallahassee, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Springfield, Illinois, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Michigan
      • Grand Rapids, Michigan, United States
      • Kalamazoo, Michigan, United States
    • Minnesota
      • Duluth, Minnesota, United States
      • Minneapolis, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New York
      • New York, New York, United States
      • Rochester, New York, United States
      • Troy, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Greenville, North Carolina, United States
      • High Point, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cleveland, Ohio, United States
      • Elyria, Ohio, United States
      • Mansfield, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Texas
      • San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 11, 2007

Last Update Submitted That Met QC Criteria

September 10, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 505-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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