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

Phase 3

• Conditions: Hypercholesterolemia
• Interventions: Drug: Niacin\Laropiprant

• Registration Number: NCT01071525
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Last Update Submitted: 2010-02-25
• Last Update Posted: 2010-03-01
• Study Start: 2010-04
• Primary Completion: 2010-08
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Hypercholesterolemia,
• age above eighteen

Exclusion Criteria

• Treatment with fibrates,
• Pregnant/Breast feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Effect on oxidative stress	three months

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel