The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects
Public ClinicalTrials.gov record NCT01893515. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled 12-Week Phase II Proof of Concept Study to Evaluate the Efficacy and Safety of PRC-4016 Once Daily Versus Placebo in Statin-Naïve or Statin-Stable Hypertriglyceridemic Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objectives of this study is * To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameters from baseline after 12 weeks of treatment. * To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters
Study identification
- NCT ID
- NCT01893515
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 87 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2013
- Primary completion
- Jun 30, 2014
- Completion
- Jun 30, 2014
- Last update posted
- Oct 29, 2015
2013 – 2014
United States locations
- U.S. sites
- 39
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Affiliated Research Center, Inc. | Huntsville | Alabama | 35801 | — |
| Terence Hart, MD | Muscle Shoals | Alabama | 35662 | — |
| Central Phoenix Medical Clinic | Phoenix | Arizona | 85020 | — |
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | — |
| National Research Institute - Wilshire | Los Angeles | California | 90057 | — |
| National Research Institute - East 118 | Los Angeles | California | 90059 | — |
| Research Across America - Santa Ana | Santa Ana | California | 92705 | — |
| Encompass Clinical Research | Spring Valley | California | 91978 | — |
| Colorado Springs Health Partners | Colorado Springs | Colorado | 80920 | — |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| Jacksonville Impotence Treatment Center | Jacksonville | Florida | 32223 | — |
| Compass Research East, LLC | Oviedo | Florida | 32765 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| Meridien Research- Tampa | Tampa | Florida | 33606 | — |
| Evanston Premier Healthcare Research LLC | Evanston | Illinois | 60201 | — |
| Medisphere Medical Research Center | Evansville | Indiana | 47714 | — |
| Heartland Research Assoc., LLC | Newton | Kansas | 67114 | — |
| Louisville Metabolic and Atherosclerosis Research Center (L-MARC) | Louisville | Kentucky | 40213 | — |
| Troy Internal Medicine, P.C. | Troy | Michigan | 48098 | — |
| Radiant Research - Edina | Edina | Minnesota | 55435 | — |
| Mercury Street Medical | Butte | Montana | 59701 | — |
| Peters Medical Research | High Point | North Carolina | 27262 | — |
| PMG Research of Raleigh, LLC | Raleigh | North Carolina | 27609 | — |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | — |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | — |
| Sterling Research Group, Ltd. - Auburn | Cincinnati | Ohio | 45219 | — |
| Metabolic and Atherosclerosis Research Center | Cincinnati | Ohio | 45227 | — |
| Columbus Clinical Research, Inc. | Columbus | Ohio | 43213 | — |
| PSB Research/P. S. Bains, M.S., D.O. | Marion | Ohio | 43302 | — |
| RAS Health Ltd | Marion | Ohio | 43302 | — |
| Lynn Health Science Institute - Oklahoma City | Oklahoma City | Oklahoma | 73112 | — |
| Willamette Valley Clinical Studies | Eugene | Oregon | 97404 | — |
| Green and Seidner Family Practice Associates | Lansdale | Pennsylvania | 19446 | — |
| UnitedResearch - Orangeburg, LLC | Orangeburg | South Carolina | 29118 | — |
| Padre Coast Clinical Research | Corpus Christi | Texas | 78404 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| National Clinical Research - Norfolk, Inc. | Norfolk | Virginia | 23502 | — |
| National Clinical Research - Richmond, Inc. | Richmond | Virginia | 23294 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01893515, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 29, 2015 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01893515 live on ClinicalTrials.gov.