Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery Disease
NCT ID: NCT00185042
Last Updated: 2007-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
534 participants
INTERVENTIONAL
2002-11-30
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Interventions
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Pactimibe, CS-505
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Locations
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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
San Diego, California, United States
Fort Collins, Colorado, United States
Bridgeport, Connecticut, United States
Newark, Delaware, United States
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
Atlanta, Georgia, United States
Springfield, Illinois, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Springfield, Massachusetts, United States
Grand Rapids, Michigan, United States
Kalamazoo, Michigan, United States
Duluth, Minnesota, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Lincoln, Nebraska, United States
New York, New York, United States
Rochester, New York, United States
Troy, New York, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
High Point, North Carolina, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Elyria, Ohio, United States
Mansfield, Ohio, United States
Oklahoma City, Oklahoma, United States
Doylestown, Pennsylvania, United States
Memphis, Tennessee, United States
San Antonio, Texas, United States
Countries
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References
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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.
Other Identifiers
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505-202
Identifier Type: -
Identifier Source: org_study_id