The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects
NCT01893515 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87
Last updated 2015-10-30
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.
* To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters
Conditions
Interventions
- DRUG
-
PRC-4016
- DRUG
Sponsors & Collaborators
-
Pronova BioPharma
lead INDUSTRY
Principal Investigators
-
Pål Nord, MD, MPH · Pronova BioPharma
-
Traci A. Turner, MD, MT · Metabolic and Atherosclerosis Research Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-31
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- United States
Study Locations
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