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The study will be conducted at up to 80 centers worldwide and will be a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease (CAD). Subjects will be randomized to receive either placebo tablets or one of 4 orally active doses of A-002. The duration of study drug therapy will be 8 weeks.
A-002 represents a novel therapy for the treatment of atherosclerosis and coronary artery disease (CAD). Through the inhibition of activity A-002 may provide multifunctional activity directed against key facets of the disease process, namely a) inflammation, b) atherogenic lipid profiles and c) the atherosclerotic process. Non-clinical and clinical data from recent studies have demonstrated the benefit of early and aggressive anti-inflammatory therapy to reduce cardiovascular risk. Recent clinical studies have provided a strong association between levels and cardiovascular event risk. The proposed Phase 2 clinical pharmacology study (Study No. AN-CVD-2221) will examine the effects of 4 different doses of A-002 compared with placebo, on enzyme levels and activity after 8 weeks of treatment. In addition, the effect of treatment on inflammatory markers of cardiovascular risk (C-reactive protein [CRP]), lipid levels and lipoprotein subclasses and other soluble biomarkers (e.g., ICAM-1, VCAM-1, TNF, MCP-1 etc) will also be assessed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-002 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses. |
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Inclusion Criteria:
Subjects are eligible for inclusion if they meet the following inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Heart Specialists | Mobile | Alabama | 36608 | United States | ||
| Sonoran Health Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19231633 | Derived | Rosenson RS, Hislop C, McConnell D, Elliott M, Stasiv Y, Wang N, Waters DD; PLASMA Investigators. Effects of 1-H-indole-3-glyoxamide (A-002) on concentration of secretory phospholipase A2 (PLASMA study): a phase II double-blind, randomised, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):649-58. doi: 10.1016/S0140-6736(09)60403-7. |
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| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Central Arkansas Research | Hot Springs | Arkansas | 71913 | United States |
| Broward General Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Hudson | Florida | United States |
| Charlotte Cardiovascuar Research | Port Charlotte | Florida | 339521 | United States |
| Florida Cardiovascular Institute | Tampa | Florida | 33609 | United States |
| Augusta Cardiology Clinic, PC | Augusta | Georgia | 30901 | United States |
| Louisville Cardiology Medical Group | Louisville | Kentucky | 40207 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| United Medical Associates | Binghamton | New York | 13901 | United States |
| Regional Clinical Research, Inc. | Endwell | New York | 13760 | United States |
| Cardiology, PC | Syracuse | New York | 13210 | United States |
| Oklahoma Cardiovascular and Hypertension Center | Oklahoma City | Oklahoma | 73132 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18105 | United States |
| Camp Hill | Pennsylvania | United States |
| Black Hills Clinical Research Center | Rapid City | South Dakota | 57701 | United States |
| Austin Heart | Austin | Texas | 78705 | United States |
| Cardiopulmonary Research Science and Technology Institute | Dallas | Texas | 75230 | United States |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | United States |
| Winsconin Heart, SC | Madison | Wisconsin | 53715 | United States |
| Strazhesko Institute of Cardiology AMS | Kyiv | 03680 | Ukraine |
| Dnipropetrovs'k State Medical Academy | Dnepropetrovs'k | 49027 | Ukraine |
| Institute of Therapy of AMS | Kharkiv | 61039 | Ukraine |
| Central Clinical Hospital "Ukrzaliznysti" | Khirkov | 61018 | Ukraine |
| Strazhesko Institute of Cardiology AMS | Kviv | 03680 | Ukraine |
| Kiev Central Hospital #1 | Kyiv | 01023 | Ukraine |
| City Clinical Hospital No 12 | Kyiv | 01103 | Ukraine |
| Scientific Centre of Endocrine Surgery | Kyiv | 02175 | Ukraine |
| Strazhesko Institute of Cardiology AMS | Kyiv | 03680 | Ukraine |
| Institute of Gerontology AMS | Kyiv | 04114 | Ukraine |
| Institute of Gerontology | Kyiv | 04114 | Ukraine |
| L'viv Regional State Clinical Treatment and Diagnostics | Lviv | 79015 | Ukraine |
| Hospital of "Radioprylad" Plant | Zaporizhzhya | 69108 | Ukraine |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C545088 | varespladib methyl |
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