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
Not provided
The objective of this study is
6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 Non-HDL-C from baseline to Week 12 | from baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in triglycerides from baseline to Week 12 | from baseline to Week 12 | |
| Change in HDL-C from baseline to Week 12 | from baseline to Week 12 | |
| Change in LDL-C from baseline to Week 12 |
Not provided
Main Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pål Nord, MD, MPH | Pronova BioPharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affiliated Research Center, Inc. | Huntsville | Alabama | 35801 | United States | ||
| Terence Hart, MD |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Statins | Drug | Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc) |
|
| 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 ApoB 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 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 |
| Change in Insulin Resistance (HOMA) from baseline to Week 12 | from baseline to Week 12 |
| Muscle Shoals |
| Alabama |
| 35662 |
| United States |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | United States |
| National Research Institute - Wilshire | Los Angeles | California | 90057 | United States |
| Research Across America - Santa Ana | Santa Ana | California | 92705 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | 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 |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| PMG Research of Raleigh, LLC | Raleigh | North Carolina | 27609 | 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 |
| Willamette Valley Clinical Studies | Eugene | Oregon | 97404 | United States |
| Green and Seidner Family Practice Associates | Lansdale | Pennsylvania | 19446 | United States |
| Padre Coast Clinical Research | Corpus Christi | Texas | 78404 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided