Clinical Trial: Efficacy Study of Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Daily Pro-Omega LDL for Low-Density Lipoprotein Cholesterol and Triglyceride Reduction in Subjects With Mixed Hyperlipoprotein

Brief Summary: Pro-Omega LDL reduces low-density lipoprotein cholesterol and triglycerides in subjects with mixed hyperlipoproteinemia.

Detailed Summary:
Sponsor: Nordic Pharma, USA

Current Primary Outcome:

  • Low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 8 weeks ]
  • Triglycerides (TG) [ Time Frame: 8 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total cholesterol [ Time Frame: 8 weeks ]
  • High-density lipoprotein cholesterol (HDL-C) [ Time Frame: 8 weeks ]
  • non-HDL-C [ Time Frame: 8 weeks ]
  • LDL-C/HDL-C ratio [ Time Frame: 8 weeks ]
  • C-reactive protein [ Time Frame: 8 weeks ]
  • Adverse events [ Time Frame: 4 and 8 weeks ]
  • Offset effect [ Time Frame: 2 weeks after withdrawal ]
    Offset effect of Pro-Omega LDL two weeks after withdrawal of placebo and Pro-Omega LDL on serum markers


Original Secondary Outcome: Same as current

Information By: Nordic Pharma, USA

Dates:
Date Received: February 20, 2014
Date Started: February 2014
Date Completion: July 2014
Last Updated: December 10, 2015
Last Verified: December 2015