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Sponsored by: |
Craigavon Area Hospital |
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Information provided by: | Craigavon Area Hospital |
ClinicalTrials.gov Identifier: | NCT00238004 |
Abnormal blood cholesterol levels increase the risk of developing, or dying from heart disease. It is well recognised that if "harmful" LDL cholesterol is high, and "protective" HDL cholesterol is low, this risk is increased. Drugs called statins are routinely used in patients with heart disease, are well tolerated, and decrease the harmful LDL cholesterol levels. However, statins only increase protective HDL cholesterol to a small extent. Some patients may thus benefit from additional medication to increase protective HDL-cholesterol further. One of the most effective drugs which can do this is nicotinic acid. This drug is well established having been available for over 30 years. Previous use has been limited by facial flushing in a large percentage of patients receiving the drug. However a new formulation called Niaspan is now available which is associated with much less flushing.
Although many patients will have transient flushing, it is estimated that only 1 patient out of every 20 receiving the drug will have to discontinue treatment. We therefore propose, in patients with coronary artery disease and low HDL cholesterol despite being on a statin, to study the effect of Niaspan on HDL cholesterol and other lipid parameters, and to assess its tolerability.
Condition | Intervention | Phase |
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HDL Cholesterol Coronary Arteriosclerosis Lipoproteins |
Drug: Nicotinic acid |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Low HDL On Six Weeks Statin Therapy (LOW) Study |
Estimated Enrollment: | 60 |
Study Start Date: | November 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The dose and type of statin should not be altered during the study period
Exclusion Criteria:
Study ID Numbers: | 2004-001690-26 |
Study First Received: | October 12, 2005 |
Last Updated: | September 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00238004 History of Changes |
Health Authority: | United Kingdom: National Health Service |
Niacin |
Antimetabolites Arterial Occlusive Diseases Vasodilator Agents Vitamin B Complex Heart Diseases Niacinamide Antilipemic Agents Myocardial Ischemia Vascular Diseases Trace Elements |
Cardiovascular Agents Arteriosclerosis Ischemia Hydroxymethylglutaryl-CoA Reductase Inhibitors Coronary Disease Nicotinic Acids Vitamins Micronutrients Niacin Coronary Artery Disease |
Antimetabolites Arterial Occlusive Diseases Vasodilator Agents Heart Diseases Niacinamide Vitamin B Complex Molecular Mechanisms of Pharmacological Action Antilipemic Agents Growth Substances Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases |
Cardiovascular Agents Arteriosclerosis Pharmacologic Actions Coronary Disease Nicotinic Acids Therapeutic Uses Vitamins Cardiovascular Diseases Micronutrients Niacin Coronary Artery Disease |