The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
| End Date: | July 2014 |
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
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
- 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
6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification
Main Inclusion Criteria:
- Fasting triglycerides 500-1500 mg/dl
- Not on other lipid altering therapy, OR on stable lipid altering therapy
Main Exclusion Criteria:
- Type I diabetes or uncontrolled type II diabetes
- Recent cardiovascular or coronary event
- History of pancreatitis
- History or evidence of major and clinically significant diseases that would interfere
with the conduct of the study or interpretation of data
- Uncontrolled hypertension
We found this trial at
39
sites
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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