Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pactimibe, CS-505 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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; |
Not provided
Inclusion Criteria:
Standard:
Angiographic:
Exclusion Criteria:
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:
Any of the following manifestations of cardiac disease:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16554527 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| - 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 |
| 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 |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C509302 | pactimibe |
Not provided
Not provided
Not provided