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NCT01071525 Clinical Trial

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

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01071525
Other study ID # Niacin-OS
Secondary ID
Status Unknown status
Phase Phase 3
First received February 18, 2010
Last updated February 25, 2010
Start date April 2010
Est. completion date October 2010

Study information
Verified date February 2010
Source Rambam Health Care Campus
Contact Shadi Hamoud, Dr
Phone +972-523591876
Email s_hamoud@rambam.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 30
Est. completion date October 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Hypercholesterolemia,

- age above eighteen

Exclusion Criteria:

- Treatment with fibrates,

- Pregnant/Breast feeding women

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Rambam Health Care Campus Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect on oxidative stress three months
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