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The Low HDL On Six Weeks Statin Therapy (LOW) Study

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ClinicalTrials.gov Identifier: NCT00238004
Recruitment Status : Unknown
Verified September 2006 by Craigavon Area Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 13, 2005
Last Update Posted : September 13, 2006
Sponsor:
Information provided by:
Craigavon Area Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
HDL Cholesterol Coronary Arteriosclerosis Lipoproteins Drug: Nicotinic acid Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Low HDL On Six Weeks Statin Therapy (LOW) Study
Study Start Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Number of patients achieving target HDL-C levels (defined as HDL-C >1.0mmol/l in males or >1.29mmol/l in females) after completion of the study protocol

Secondary Outcome Measures :
  1. Incidence and severity of flushing


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persisting low HDL-C (<0.9mmol/l) on a full lipid profile result (which for inpatients should have been taken <24 hours after admission).
  • Objective diagnosis of coronary heart disease (previous biomarker proven MI, positive stress test, angiogram with at least one >50% diameter stenosis)
  • Established for at least 6 weeks on a “maintenance” dose of statin therapy (defined as Pravastatin 40mg, Simvastatin 40mg or Atorvastatin ≥10mg). The dose and type of statin should not be altered during the study period
  • Absence of concurrent major systemic illness (particularly liver or renal failure, or hypo or hyperthyroidism)

Exclusion Criteria:

  • Previous use of Niaspan or other non-statin lipid lowering agent within the previous 12 weeks
  • Contraindications to Niaspan therapy
  • Participation in another medical trial within the previous 30days
  • Failure to obtain informed consent

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): NCT00238004


Locations
United Kingdom
Craigavon Cardiac Centre
Craigavon, United Kingdom
Sponsors and Collaborators
Craigavon Area Hospital
Investigators
Principal Investigator: I Menown, MD FRCP Craigavon Area Hospital

ClinicalTrials.gov Identifier: NCT00238004     History of Changes
Other Study ID Numbers: 2004-001690-26
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: September 13, 2006
Last Verified: September 2006

Keywords provided by Craigavon Area Hospital:
Niacin

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Nicotinic Acids
Niacin
Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents