The Effect of Niacin Administration on Oxidative Stress in Patients With Hypercholesterolmia, as Measured by the Use of a Novel Biomarker

Overview

1. Treatment of Hypercholesterolemic patients with niacin will cause a significant decrease in oxidative stress and a decrease in the atherogenecity in blood samples of the patients. 2. A possible correlation between oxidative stress in hypercholesterolemic patients taking niacin to clinical hypercholesterolemia parameters is possible. 3. Using a novel biomarker will enable a precise detection of the change in the oxidative stress in hypercholesterolemic patients.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2010

Interventions

  • Drug: Niacin\Laropiprant
    • Hypercholesterolemic patients with low HDL will receive Niacin\Laropiprant

Arms, Groups and Cohorts

  • Active Comparator: Niacin
    • Hypercholesterolemic patients with high-density lipoprotein (HDL) less than 40 mg% will receive Niacin\Laropiprant.
  • No Intervention: Control
    • Maching subjects will receive no medication, Blood tests will be drawn for laboratory tests.

Clinical Trial Outcome Measures

Primary Measures

  • Effect on oxidative stress
    • Time Frame: three months

Participating in This Clinical Trial

Inclusion Criteria

  • Hypercholesterolemia, – age above eighteen Exclusion Criteria:

  • Treatment with fibrates, – Pregnant/Breast feeding women

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Dr Shadi Hamoud, Rambam Health Care Campus
  • Overall Official(s)
    • Liz Phima, Study Director, Study Coordinator
  • Overall Contact(s)
    • Shadi Hamoud, Dr, +972-523591876, s_hamoud@rambam.health.gov.il

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