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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Craigavon Area Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Craigavon Area Hospital
ClinicalTrials.gov Identifier:
NCT00238004
First received: October 12, 2005
Last updated: September 11, 2006
Last verified: September 2006
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Low HDL On Six Weeks Statin Therapy (LOW) Study

Resource links provided by NLM:


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
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: 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

No publications provided

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

Keywords provided by Craigavon Area Hospital:
Niacin

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases
Nicotinic Acids
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014