The Low HDL On six Weeks statin therapy (LOW) study
- Conditions
- Dyslipidaemia (low HDL-cholesterol)
- Registration Number
- EUCTR2004-001690-26-GB
- Lead Sponsor
- Craigavon Area Hospital Group Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Persisting low HDL-C (<0.9mmol/l) on a full lipid profile result (which for inpatients should have been taken <24 hours after admission).
2. Objective diagnosis of coronary heart disease (previous biomarker proven MI, positive stress test, angiogram with at least one >50% diameter stenosis)
3. 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
4. Absence of concurrent major systemic illness (particularly liver or renal failure, or hypo or hyperthyroidism)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Previous use of Niaspan or other non-statin lipid lowering agent within the previous 12 weeks
2. Contraindications to Niaspan therapy
3. Participation in another medical trial within the previous 30days
4. Failure to obtain informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the number of patients with low HDL cholesterol 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 while taking Niaspan compared with placebo;Secondary Objective: To assess the efficacy of Niapsan on other lipid parameters and C-reactive protein<br>To assess the tolerability of Niaspan by measuring standard blood tests and a patient questionnaire<br>;Primary end point(s): The number of patients with low HDL cholesterol 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 while taking Niaspan compared with placebo.
- Secondary Outcome Measures
Name Time Method