Clinical Trial: Comparison of Coenzyme A and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Head-to-Head Comparison of Coenzyme A Capsule and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia: A Phase III, Multicenter, Double-blinded, Double Dummy Clinical Trial.

Brief Summary: The purpose of this study is to compare the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A capsule with a marketed drug, fenofibrate, in Chinese patients with moderate dyslipidemia.

Detailed Summary: Although lowering cholesterol and low-density lipoprotein-cholesterol (LDL-C) is the mainstay of medical therapy for cardiovascular event prevention, evidence from clinical trials supports a role for elevated triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) concentrations in the residual cardiovascular risk on statin treatment. Fenofibrate is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining with statin, which lowers TG and raises HDL-C through multifaceted mechanism by PPARα activation. However, safety of coadministration of statin with fenofibrate has been a great concern, especially drug-induced hepatotoxicity when they are combined used. Coenzyme A (CoA) functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. Animal studies have proved its lipid-lowering effects. In a previous multicenter study we conducted in 2008, it was found that oral CoA 400U/d effectively lowered serum TG levels in hypertriglyceridemia patients without increasing adverse effects when compared with placebo. So, the present study was performed to further investigate the lipid-lowing effects and safety of CoA capsule by comparing with fenofibrate.
Sponsor: Zhejiang University

Current Primary Outcome: serum triglyceride level [ Time Frame: 10 months ]

The primary efficacy variable was the percentage change in serum lipid level from baseline to 4 and 8 weeks of treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • serum total cholesterol level [ Time Frame: 10 months ]
    change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level.
  • low-density lipoprotein cholesterol level [ Time Frame: 10 months ]
    change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level.
  • serum high-density lipoprotein cholesterol level [ Time Frame: 10 months ]
    change from baseline to 4 and 8 weeks of treatment in serum high-density lipoprotein cholesterol level.


Original Secondary Outcome: Same as current

Information By: Zhejiang University

Dates:
Date Received: June 10, 2013
Date Started: July 2010
Date Completion:
Last Updated: June 11, 2013
Last Verified: June 2013