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The Low HDL On Six Weeks Statin Therapy (LOW) Study
This study is ongoing, but not recruiting participants.
Sponsored by: Craigavon Area Hospital
Information provided by: Craigavon Area Hospital
ClinicalTrials.gov Identifier: NCT00238004
  Purpose

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
HDL Cholesterol
Coronary Arteriosclerosis
Lipoproteins
Drug: Nicotinic acid
Phase IV

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases Statins
Drug Information available for: Niacin Niacin hydrochloride
U.S. FDA Resources
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

Further study details as provided by Craigavon Area Hospital:

Primary Outcome Measures:
  • 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:
  • Incidence and severity of flushing

Estimated Enrollment: 60
Study Start Date: November 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Study ID Numbers: 2004-001690-26
Study First Received: October 12, 2005
Last Updated: September 11, 2006
ClinicalTrials.gov Identifier: NCT00238004  
Health Authority: United Kingdom: National Health Service

Keywords provided by Craigavon Area Hospital:
Niacin

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Nicotinic Acids
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Niacin
Coronary Artery Disease

Additional relevant MeSH terms:
Antimetabolites
Vasodilator Agents
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Antilipemic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Pharmacologic Actions
Vitamins
Therapeutic Uses
Cardiovascular Diseases
Micronutrients

ClinicalTrials.gov processed this record on January 14, 2009