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

Primary Purpose

Hypercholesterolemia

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Niacin\Laropiprant
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Hypercholesterolemia,
  • age above eighteen

Exclusion Criteria:

  • Treatment with fibrates,
  • Pregnant/Breast feeding women

Sites / Locations

  • Rambam Health Care Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Niacin

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effect on oxidative stress

Secondary Outcome Measures

Full Information

First Posted
February 18, 2010
Last Updated
February 25, 2010
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01071525
Brief Title
The Effect of Niacin Administration on Oxidative Stress in Patients With Hypercholesterolmia, as Measured by the Use of a Novel Biomarker
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. A possible correlation between oxidative stress in hypercholesterolemic patients taking niacin to clinical hypercholesterolemia parameters is possible. Using a novel biomarker will enable a precise detection of the change in the oxidative stress in hypercholesterolemic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Niacin
Arm Type
Active Comparator
Arm Description
Hypercholesterolemic patients with high-density lipoprotein (HDL) less than 40 mg% will receive Niacin\Laropiprant.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Maching subjects will receive no medication, Blood tests will be drawn for laboratory tests.
Intervention Type
Drug
Intervention Name(s)
Niacin\Laropiprant
Intervention Description
Hypercholesterolemic patients with low HDL will receive Niacin\Laropiprant
Primary Outcome Measure Information:
Title
Effect on oxidative stress
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hypercholesterolemia, age above eighteen Exclusion Criteria: Treatment with fibrates, Pregnant/Breast feeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shadi Hamoud, Dr
Phone
+972-523591876
Email
s_hamoud@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liz Phima
Organizational Affiliation
Study Coordinator
Official's Role
Study Director
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shadi
Phone
+972-523591876
Email
s_hamoud@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Tony Hayek, Prof
Phone
+972-523782009
Email
t_hayek@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Tony Hayek, Prof

12. IPD Sharing Statement

Learn more about this trial

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

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