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

February 25, 2010 updated by: Rambam Health Care Campus
  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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hypercholesterolemia,
  • age above eighteen

Exclusion Criteria:

  • Treatment with fibrates,
  • Pregnant/Breast feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Niacin
Hypercholesterolemic patients with high-density lipoprotein (HDL) less than 40 mg% will receive Niacin\Laropiprant.
Drug: Niacin\Laropiprant
Hypercholesterolemic patients with low HDL will receive Niacin\Laropiprant
NO_INTERVENTION: Control
Maching subjects will receive no medication, Blood tests will be drawn for laboratory tests.
Drug: Niacin\Laropiprant
Hypercholesterolemic patients with low HDL will receive Niacin\Laropiprant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect on oxidative stress
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Study Director: Liz Phima, study coordinator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2010

Study Completion (ANTICIPATED)

October 1, 2010

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (ESTIMATE)

February 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 1, 2010

Last Update Submitted That Met QC Criteria

February 25, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Niacin-OS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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