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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185042
First received: September 9, 2005
Last updated: September 10, 2007
Last verified: September 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185042

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

No publications provided by Daiichi Sankyo Inc.

Additional 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
Study First Received: September 9, 2005
Last Updated: September 10, 2007
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014