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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01071525
First received: February 18, 2010
Last updated: February 25, 2010
Last verified: February 2010
  Purpose
  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 Intervention Phase
Hypercholesterolemia
Drug: Niacin\Laropiprant
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Effect on oxidative stress [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hypercholesterolemia,
  • age above eighteen

Exclusion Criteria:

  • Treatment with fibrates,
  • Pregnant/Breast feeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071525

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

Locations
Israel
Rambam Health Care Campus Not yet recruiting
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
Study Director: Liz Phima Study Coordinator
  More Information

No publications provided

Responsible Party: Dr Shadi Hamoud, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01071525     History of Changes
Other Study ID Numbers: Niacin-OS
Study First Received: February 18, 2010
Last Updated: February 25, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Niacinamide
Nicotinic Acids
Antimetabolites
Cardiovascular Agents
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 20, 2014