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

NCT ID: NCT01071525

Last Updated: 2010-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Niacin

Hypercholesterolemic patients with high-density lipoprotein (HDL) less than 40 mg% will receive Niacin\\Laropiprant.

Group Type ACTIVE_COMPARATOR

Niacin\Laropiprant

Intervention Type DRUG

Hypercholesterolemic patients with low HDL will receive Niacin\\Laropiprant

Control

Maching subjects will receive no medication, Blood tests will be drawn for laboratory tests.

Group Type NO_INTERVENTION

Niacin\Laropiprant

Intervention Type DRUG

Hypercholesterolemic patients with low HDL will receive Niacin\\Laropiprant

Interventions

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Niacin\Laropiprant

Hypercholesterolemic patients with low HDL will receive Niacin\\Laropiprant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypercholesterolemia,
* age above eighteen

Exclusion Criteria

* Treatment with fibrates,
* Pregnant/Breast feeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Rambam Health Care Campus

Principal Investigators

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Liz Phima

Role: STUDY_DIRECTOR

Study Coordinator

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Shadi Hamoud, Dr

Role: CONTACT

+972-523591876

Facility Contacts

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Shadi

Role: primary

+972-523591876

Tony Hayek, Prof

Role: backup

+972-523782009

Other Identifiers

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Niacin-OS

Identifier Type: -

Identifier Source: org_study_id

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