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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials