Clinical Trial: Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A 12-Week, Randomized, Double-Blind, Corn Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in Subjects With Severe Hyp

Brief Summary: The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects with severe hypertriglyceridemia (TGs ≥500 mg/dL but ＜2000 mg/dL).

Detailed Summary:
Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Current Primary Outcome: End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • End-of-treatment non-HDL-C percentage change from baseline under fasting conditions [ Time Frame: 12 weeks ]
  • End-of-treatment TC percentage change from baseline under fasting conditions [ Time Frame: 12 weeks ]
  • End-of-treatment VLDL-C percentage change from baseline under fasting conditions [ Time Frame: 12 weeks ]
  • End-of-treatment HDL-C percentage change from baseline under fasting conditions [ Time Frame: 12 weeks ]
  • End-of-treatment LDL-C percentage change from baseline under fasting conditions [ Time Frame: 12 weeks ]
  • End-of-treatment LDL-C/HDL-C percentage change from baseline under fasting conditions [ Time Frame: 12 weeks ]
  • End-of-treatment Apo A5 percentage change from baseline under fasting conditions [ Time Frame: 12 weeks ]
  • End-of-treatment Apo C3 percentage change from baseline under fasting conditions [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Jiangsu HengRui Medicine Co., Ltd.

Dates:
Date Received: December 7, 2015
Date Started: December 2015
Date Completion:
Last Updated: December 7, 2015
Last Verified: December 2015