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Study Status: Withdrawn
Recruit Status: Withdrawn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