Efficacy and Safety of PRC-4016 in Subjects With Mixed Dyslipidemia
| Status: | Terminated |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | August 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 600 mg Once Daily Versus Placebo in Statin-Stable Subjects With Mixed Dyslipidemia
The objective of this study is
- To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood
lipids and lipoprotein parameter 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 parameter 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 200-499 mg/dl
- Non-HDL-C > 130 mg/dl
- Stable statin treatment
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
29
sites
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