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Coronary Heart DiseasePhase 2NCT00185042

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

A Phase 2 study testing Pactimibe, CS-505 in people with Coronary Heart Disease, run by Daiichi Sankyo at 46 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Heart Disease
What is being tested?
Pactimibe, CS-505
How many people
534 participants
Where
46 sitesUnited States
Study dates
Nov 2002to Jul 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Standard:
  • Male or female subjects, age 18 years or greater; and
  • Diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography.
  • Angiographic:
  • Evidence of coronary heart disease
  • Identification of a target native coronary artery for the plaque volume measurement.

Who cannot join

  • Standard:
  • Breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months;
  • Previous heart or other organ transplantation;
  • Treatment with any of the following agents within 4 weeks prior to randomization:
  • Immunosuppressive agents (cyclosporine, azathioprine);
  • Rifampin; and
Show all 21Show fewer
  • Phenytoin, phenobarbital, valproic acid, or other anticonvulsants.
  • 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.
  • Stroke (CVA) within previous 3 months;
  • Evidence of severe symptomatic heart failure (NYHA Class III or IV) or known ejection fraction less than 30%;
  • Uncontrolled diabetes mellitus;
  • Uncontrolled hypertension; and
  • Nephrotic syndrome, significant nephropathy, or other significant renal disease.
  • Angiographic:
  • Presence of any lesion with greater than 50% reduction in lumen diameter; or
  • Any lesion with a greater than 50% occlusion in the left main coronary artery;
  • 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);
  • A target vessel that is itself a bypass graft.

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

United States46 sites

  • Study site

    Akron, Ohio

  • Study site

    Atlanta, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Birmingham, Alabama

  • Study site

    Bridgeport, Connecticut

  • Study site

    Charlotte, North Carolina

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Duluth, Minnesota

  • Study site

    Elyria, Ohio

  • Study site

    Fort Collins, Colorado

  • Study site

    Gainsville, Florida

  • Study site

    Grand Rapids, Michigan

  • Study site

    Greenville, North Carolina

  • Study site

    High Point, North Carolina

  • Study site

    Hudson, Florida

  • Study site

    Huntsville, Alabama

  • Study site

    Jacksonville, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kansas City, Missouri

  • Study site

    Lincoln, Nebraska

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Mansfield, Ohio

  • Study site

    Melbourne, Florida

  • Study site

    Memphis, Tennessee

  • Study site

    Miami, Florida

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mobile, Alabama

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Pensacola, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Port Charlotte, Florida

  • Study site

    Rochester, New York

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Sarasota, Florida

  • Study site

    Springfield, Illinois

  • Study site

    Springfield, Massachusetts

  • Study site

    Tallahassee, Florida

  • Study site

    Tampa, Florida

  • Study site

    Troy, New York

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

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)

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).

Being tested
Pactimibe, CS-505
Keywords
Atherosclerosis, intravascular ultrasound
Medical subject headings
Coronary Disease, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pactimibe, CS-505Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 outcomes (8)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startNov 2002
  3. Study completionJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
534 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00185042
Sponsor's protocol ID
505-202
Status last verified
Sep 2007
First submitted
9 Sep 2005
Last updated
11 Sep 2007
Results posted
No

Publications

  • Nissen SE, Tuzcu EM, Brewer HB, Sipahi I, Nicholls SJ, Ganz P, Schoenhagen P, Waters DD, Pepine CJ, Crowe TD, Davidson MH, Deanfield JE, Wisniewski LM, Hanyok JJ, Kassalow LM; ACAT Intravascular Atherosclerosis Treatment Evaluation (ACTIVATE) Investigators. Effect of ACAT inhibition on the progression of coronary atherosclerosis. N Engl J Med. 2006 Mar 23;354(12):1253-63. doi: 10.1056/NEJMoa054699.

    PubMed 16554527

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pactimibe, CS-505 in people with Coronary Heart Disease, run by Daiichi Sankyo at 46 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00185042, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2007.

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