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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01071525
Recruitment Status : Unknown
Verified February 2010 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : February 19, 2010
Last Update Posted : March 1, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Niacin\Laropiprant Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2010
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Effect on oxidative stress [ Time Frame: three months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hypercholesterolemia,
  • age above eighteen

Exclusion Criteria:

  • Treatment with fibrates,
  • Pregnant/Breast feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071525


Contacts
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Contact: Shadi Hamoud, Dr +972-523591876 s_hamoud@rambam.health.gov.il

Locations
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Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Contact: Shadi    +972-523591876    s_hamoud@rambam.health.gov.il   
Contact: Tony Hayek, Prof    +972-523782009    t_hayek@rambam.health.gov.il   
Sub-Investigator: Tony Hayek, Prof         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Study Director: Liz Phima Study Coordinator
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Responsible Party: Dr Shadi Hamoud, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01071525    
Other Study ID Numbers: Niacin-OS
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: March 1, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs