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The objectives of this study is
6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRC-4016 | Experimental | PRC-4016, oral administration once daily, capsule |
|
| Placebo | Placebo Comparator | Placebo, oral administration once daily, capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRC-4016 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in triglycerides from baseline to week 12 | from baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HDL-C from baseline to Week 12 | from baseline to Week 12 | |
| Change in non-HDL-C from baseline to Week 12 | from baseline to Week 12 | |
| Change in LDL-C from baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments will include adverse events, clinical laboratory measurements (chemistry, hematology, and urinalysis), 12-lead ECGs, blood pressure, and physical examinations. | Up to 12 weeks |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pål Nord, MD, MPH | Pronova BioPharma | Study Director |
| Traci A. Turner, MD, MT | Metabolic and Atherosclerosis Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affiliated Research Center, Inc. | Huntsville | Alabama | 35801 | United States | ||
| Terence Hart, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26892135 | Derived | Bays HE, Hallen J, Vige R, Fraser D, Zhou R, Hustvedt SO, Orloff DG, Kastelein JJ. Icosabutate for the treatment of very high triglycerides: A placebo-controlled, randomized, double-blind, 12-week clinical trial. J Clin Lipidol. 2016 Jan-Feb;10(1):181-91.e1-2. doi: 10.1016/j.jacl.2015.10.012. Epub 2015 Nov 14. |
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|
| from baseline to week 12 |
| Change in VLDL-C from baseline to Week 12 | from baseline to week 12 |
| Change in total cholesterol from baseline to Week 12 | from baseline to week 12 |
| Change in ApoA1 from baseline to Week 12 | from baseline to Week 12 |
| Change in Apo B from baseline to Week 12 | from baseline to week 12 |
| Change in insulin from baseline to Week 12 | from baseline to Week 12 |
| Change in fasting plasma glucose from baseline to Week 12 | from baseline to Week 12 |
| Change in HbA1c from baseline to Week 12 | from baseline to Week 12 |
| Change in insulin resistance (HOMA) from baseline to Week 12 | from baseline to Week 12 |
| Change in Lp-PLA2 from baseline to Week 12 | from baseline to Week 12 |
| Change in hsCRP from baseline to Week 12 | from baseline to Week 12 |
| Change in red blood cell content of EPA and DHA from baseline to Week 12; | from baseline to Week 12; |
| Muscle Shoals |
| Alabama |
| 35662 |
| United States |
| Central Phoenix Medical Clinic | Phoenix | Arizona | 85020 | United States |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | United States |
| National Research Institute - Wilshire | Los Angeles | California | 90057 | United States |
| National Research Institute - East 118 | Los Angeles | California | 90059 | United States |
| Research Across America - Santa Ana | Santa Ana | California | 92705 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Colorado Springs Health Partners | Colorado Springs | Colorado | 80920 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| Jacksonville Impotence Treatment Center | Jacksonville | Florida | 32223 | United States |
| Compass Research East, LLC | Oviedo | Florida | 32765 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| Meridien Research- Tampa | Tampa | Florida | 33606 | United States |
| Evanston Premier Healthcare Research LLC | Evanston | Illinois | 60201 | United States |
| Medisphere Medical Research Center | Evansville | Indiana | 47714 | United States |
| Heartland Research Assoc., LLC | Newton | Kansas | 67114 | United States |
| Louisville Metabolic and Atherosclerosis Research Center (L-MARC) | Louisville | Kentucky | 40213 | United States |
| Troy Internal Medicine, P.C. | Troy | Michigan | 48098 | United States |
| Radiant Research - Edina | Edina | Minnesota | 55435 | United States |
| Mercury Street Medical | Butte | Montana | 59701 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| PMG Research of Raleigh, LLC | Raleigh | North Carolina | 27609 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Sterling Research Group, Ltd. - Auburn | Cincinnati | Ohio | 45219 | United States |
| Metabolic and Atherosclerosis Research Center | Cincinnati | Ohio | 45227 | United States |
| Columbus Clinical Research, Inc. | Columbus | Ohio | 43213 | United States |
| PSB Research/P. S. Bains, M.S., D.O. | Marion | Ohio | 43302 | United States |
| RAS Health Ltd | Marion | Ohio | 43302 | United States |
| Lynn Health Science Institute - Oklahoma City | Oklahoma City | Oklahoma | 73112 | United States |
| Willamette Valley Clinical Studies | Eugene | Oregon | 97404 | United States |
| Green and Seidner Family Practice Associates | Lansdale | Pennsylvania | 19446 | United States |
| UnitedResearch - Orangeburg, LLC | Orangeburg | South Carolina | 29118 | United States |
| Padre Coast Clinical Research | Corpus Christi | Texas | 78404 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| National Clinical Research - Norfolk, Inc. | Norfolk | Virginia | 23502 | United States |
| National Clinical Research - Richmond, Inc. | Richmond | Virginia | 23294 | United States |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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