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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185042
First Posted: September 16, 2005
Last Update Posted: September 11, 2007
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.
Information provided by:
Daiichi Sankyo, Inc.
  Purpose
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 Intervention Phase
Coronary Heart Disease Drug: Pactimibe, CS-505 Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

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

Enrollment: 534
Study Start Date: November 2002
Estimated Study Completion Date: July 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


  Show 46 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00185042     History of Changes
Other Study ID Numbers: 505-202
First Submitted: September 9, 2005
First Posted: September 16, 2005
Last Update Posted: September 11, 2007
Last Verified: September 2007

Keywords provided by Daiichi Sankyo, Inc.:
Atherosclerosis, intravascular ultrasound

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases