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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185042
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 11, 2007
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : November 2002
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. To compare the effect of CS-505 versus placebo when added to usual medical care on:
  2. - change from baseline in total atheroma volume in
  3. various arteries;
  4. - changes in minimum luminal diameter and percent
  5. diameter stenosis;
  6. - incidence and time to first occurrence of
  7. cardiovascular events.
  8. To compare the safety of CS-505 versus placebo

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185042


Locations
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United States, Alabama
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, California
Los Angeles, California, United States
San Diego, California, United States
United States, Colorado
Fort Collins, Colorado, United States
United States, Connecticut
Bridgeport, Connecticut, United States
United States, Delaware
Newark, Delaware, United States
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
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Springfield, Illinois, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Michigan
Grand Rapids, Michigan, United States
Kalamazoo, Michigan, United States
United States, Minnesota
Duluth, Minnesota, United States
Minneapolis, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, New York
New York, New York, United States
Rochester, New York, United States
Troy, New York, United States
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
United States, Ohio
Akron, Ohio, United States
Cleveland, Ohio, United States
Elyria, Ohio, United States
Mansfield, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Doylestown, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Daiichi Sankyo, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00185042    
Other Study ID Numbers: 505-202
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 11, 2007
Last Verified: September 2007
Keywords provided by Daiichi Sankyo, Inc.:
Atherosclerosis, intravascular ultrasound
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases