Trials / Completed
CompletedNCT04756180
An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 248 (actual)
- Sponsor
- Abbott · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This was a multicenter, randomized, double-blind, parallel-group study of twice daily treatment of Omacor or matching placebo in subjects with moderate or severe HTG.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omega-3-acid ethyl ester or Placebo | Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2019-04-01
- Completion
- 2019-04-01
- First posted
- 2021-02-16
- Last updated
- 2021-03-05
Source: ClinicalTrials.gov record NCT04756180. Inclusion in this directory is not an endorsement.