Dyslipidaemia (low HDL-cholesterol)
Conditions
Interventions
Trade Name: Niaspan
Product Name: Niaspan
Product Code: n/a
Pharmaceutical Form: Prolonged-release tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Craigavon Area Hospital Group Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Persisting low HDL-C (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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 To assess the tolerability of Niaspan by measuring standard blood tests and a patient questionnaire ;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. | — |
Countries
United Kingdom
Outcome results
None listed