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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Information provided by:
Rambam Health Care Campus Identifier:
First received: February 18, 2010
Last updated: February 25, 2010
Last verified: February 2010
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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


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

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 identifier: NCT01071525

Contact: Shadi Hamoud, Dr +972-523591876

Rambam Health Care Campus Not yet recruiting
Haifa, Israel, 31096
Contact: Shadi    +972-523591876   
Contact: Tony Hayek, Prof    +972-523782009   
Sub-Investigator: Tony Hayek, Prof         
Sponsors and Collaborators
Rambam Health Care Campus
Study Director: Liz Phima Study Coordinator
  More Information

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

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on September 19, 2017