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The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pactimibe sulfate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effects of pactimibe versus placebo, when added to usual medical care: | ||
| - on the incidence and the time to first occurrence of | ||
| cardiovascular events, |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Ana | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19293413 | Derived | Meuwese MC, de Groot E, Duivenvoorden R, Trip MD, Ose L, Maritz FJ, Basart DC, Kastelein JJ, Habib R, Davidson MH, Zwinderman AH, Schwocho LR, Stein EA; CAPTIVATE Investigators. ACAT inhibition and progression of carotid atherosclerosis in patients with familial hypercholesterolemia: the CAPTIVATE randomized trial. JAMA. 2009 Mar 18;301(11):1131-9. doi: 10.1001/jama.301.11.1131. |
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| - on inflammatory and oxidative markers, such as serum |
| high-sensitivity C-reactive protein (hsCRP), plasma |
| interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and |
| serum nitrotyrosine. |
| To compare the safety of pactimibe versus placebo, when added to usual medical care, particularly with respect to the incidence of clincal and laboratory adverse events. |
| Chicago |
| Illinois |
| United States |
| Baltimore | Maryland | United States |
| St Louis | Missouri | United States |
| Cincinnati | Ohio | United States |
| Houston | Texas | United States |
| Salt Lake City | Utah | United States |
| Seattle | Washington | United States |
| Vancouver | British Columbia | Canada |
| Toronto | Ontario | Canada |
| Chicoutimi | Quebec | Canada |
| Chomedey Laval | Quebec | Canada |
| Montreal | Quebec | Canada |
| Ste-Foy | Quebec | Canada |
| Jerusalem | Israel |
| Amsterdam | Zuidoost | Netherlands |
| Capelle aan den IJssel | Netherlands |
| Dordrecht | Netherlands |
| Etten-Leur | Netherlands |
| Goes | Netherlands |
| Gorinchem | Netherlands |
| Gouda | Netherlands |
| Groningen | Netherlands |
| Hoorn | Netherlands |
| Leiden | Netherlands |
| Rotterdam | Netherlands |
| Tilburg | Netherlands |
| Oslo | Norway |
| Bellville | South Africa |
| Midrand | South Africa |
| Pretoria | South Africa |
| Barcelona | Spain |
| Córdoba | Spain |
| Linköping | Sweden |
| Stockholm | Sweden |
| London | United Kingdom |
| Manchester | United Kingdom |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C509302 | pactimibe |
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