Last updated: March 3, 2021
Sponsor: Abbott
Overall Status: Completed
Phase
3
Condition
Hypertriglyceridemia
Treatment
N/AClinical Study ID
NCT04756180
PUFA3001
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Baseline fasting serum TG level > 200mg/dL and <1000mg/dL, in subjects treated forHTG.
- If on previous statin therapy, the treatment should have been kept stable in the last 3 months before entering the study.
- Able and willing to give written informed consent.
Exclusion
Exclusion Criteria:
- Subjects taking fish oil capsules 8 weeks prior to inclusion in this study.
- Known allergy to the active ingredient, or fish, soya, corn or olive oild (placebos).
- Pregnant of lactating females.
- Known increased risk of hemorrhage such as recent surgery, gastrointestinalhemorrhagic disease.
- Significant hepatic disease.
- Significantly reduced renal function.
- Alcohol consumption >30g for male and 20g for female daily.
- Concomitant use of other investigational drugs.
- Subject related to the investigator.
- Subject expected to be not compliant.
Study Design
Total Participants: 248
Study Start date:
October 01, 2016
Estimated Completion Date:
April 30, 2019