Hypercholesterolemia MedDRA version: 9.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia
Conditions
Interventions
Trade Name: Niaspan
Pharmaceutical Form: Tablet
INN or Proposed INN: Nicotinic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the
Sponsors
Faculdade de Ciências Médicas – Universidade Nova de Lisboa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - more or equal than 18 years of age; - Signed written informed consent before any study related activities are carried out; - Effective contraception for female subjects if risk of conception exists; - HDL less or equal to 40 mg/dl in men or HDL less or equal to 50 mg/dl in women; - Patients with dietary counselling. 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: - Pregnancy (absence confirmed by serum b-HCG test at screening visit) or lactation period; - Medical or psychological condition that would not permit the subject to complete the study or sign inform consent; - Known drug abuse (with the exception of alcohol abuse); - Known active peptic ulcer; - Known active arterial hemorrhage; - LDL more than 180 mg/dl and triglycerides more than 200 mg/dl; - Total bilirubin less or equal to 2 x upper limit of normality (ULN); aspartate-aminotransferase (AST) and alanine-aminotransferase (ALT) less or equal to 3 x ULN; - Creatinine clearance more than 60 ml/min; - Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia; - Diabetes mellitus or other relevant cardiovascular disease; - Known allergies against any of the components of the study treatment; - Any investigational medication within 30 days before study entry; - Treatment with statins, fibrates anti-oxidant during the 8 weeks prior to enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate de effect of Niaspan in Paraoxonase activity compared with placebo;Secondary Objective: 1. To determine whether the effect of study treatment in Paraoxonase activity is independent of plasma HDL concentration; 2. To determine whether the effect of study treatment in plasma oxidation markers is independent of plasma HDL concentration; 3. To determine whether the effect of study treatment in Serum Nitric Oxide is independent of plasma HDL concentration; 4. To determine whether the effect of study treatment in Anti-HDL antibodies concentration is independent of plasma HDL concentration; 5. To determine the safety and tolerability of study treatment. ;Primary end point(s): Change in Paraoxonase activity in serum after treatment period. | — |
Countries
Portugal
Outcome results
None listed