Hypertriglyceridemia Clinical Trial
Official title:
A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Parallel Group Study to Investigate the Efficacy and Safety of Omega-3-acid Ethyl Ester Over 12 Weeks in Chinese Subjects With Hypertriglyceridemia
NCT number | NCT04756180 |
Other study ID # | PUFA3001 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | April 2019 |
Verified date | March 2021 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective was to investigate the effect of 12-week treatment of Omacor on fasting serum triglycerides (TG) in Chinese subjects with hypertriglyceridemia (HTG). The secondary objectives were to investigate the safety and tolerability and effect of Omacor on lipid parameters after 12 weeks treatment.
Status | Completed |
Enrollment | 248 |
Est. completion date | April 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Baseline fasting serum TG level > 200mg/dL and <1000mg/dL, in subjects treated for HTG. - 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 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, gastrointestinal hemorrhagic 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent change in fasting serum TG | Percent change from baseline in fasting serum TG | Baseline to end of treatment at treatment week 12 | |
Secondary | Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio | Change from baseline in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio | Between baseline and end of treatment week 12 |
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