Status:
COMPLETED
The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects
Lead Sponsor:
Pronova BioPharma
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
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. * T...
Detailed Description
6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification
Eligibility Criteria
Inclusion
- Main
- Fasting triglycerides 500-1500 mg/dl
- Not on other lipid altering therapy, OR on stable lipid altering therapy
- Main
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01893515
Start Date
July 1 2013
End Date
July 1 2014
Last Update
October 30 2015
Active Locations (39)
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1
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
2
Terence Hart, MD
Muscle Shoals, Alabama, United States, 35662
3
Central Phoenix Medical Clinic
Phoenix, Arizona, United States, 85020
4
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211