Lipoprotein (Lp)(a) has been associated with an increased risk of coronary heart disease, cerebrovascular disease, and peripheral arterial vascular disease. Potential therapies to reduce elevated Lp(a) levels include nicotinic acid (niacin), but there is a lack of randomised controlled studies assessing the effectiveness of these therapies in lowering Lp(a) as a primary endpoint and in reducing cardiovascular events in the long term.
Conditions
Interventions
Trade Name: Niaspan
Pharmaceutical Form:
INN or Proposed INN: NICOTINIC ACID
CAS Number: 59676
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Lp(a) plasma levels > 30 mg/dl as measured twice - Male or female subjects, aged 18 – 75 years - With and without cardiovascular diseases - Triglyceride levels =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Known hypertriglyceridaemia or fasting triglycerides > 400 mg/dl - Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia - Documented secondary hypercholesterolaemia of any cause - Initiation or dose change of a lipid-modifying drug within the last four weeks - Known hypersensitivity to nicotinic acid or any components or their derivatives - Concurrent treatment with products containing significant amounts of niacin or nicotinamide - Concurrent treatment with an immediate release formulation of nicotinic acid or a nicotinic acid analogue, e.g. supplements - Cardiovascular diseases which are contra-indicated - Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception - History of malignancy within preceding 10 years - Use of disallowed concomitant medication - History of alcohol or drug abuse, or both - Active liver disease or hepatic dysfunction - Known uncontrolled or poorly controlled diabetes - Persistent uncontrolled or untreated hypertension - Unexplained serum creatine phosphokinase (CK) >3 times the ULN in the last 4 weeks before the randomisation visit - History of severe myalgia of unknown origin - Arterial bleeding - Active peptic ulcer - Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins - Active gout symptoms - Significant renal insufficiency - Planned hospitalizations for diagnostic or surgical procedures within the next 5 months - Known infectious disease such as hepatitis or HIV - Participation in another investigational drug trial within the four weeks prior to study entry - Previous randomisation into this study - Subjects with serious or unstable medical or psychological condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of niacin therapy on mean change in Lp(a) levels to placebo.;Secondary Objective: - To compare the effect of niacin therapy on mean change in plasma lipids levels to placebo - To compare the effect of niacin therapy on mean change in blood glucose levels to placebo. - To compare the effect of niacin therapy on health-related quality of life (Short Form (SF)-12, EQ-5D) - To compare the effect of niacin therapy on cumulative disease-related costs to placebo. - To compare safety and tolerability in patients with niacin therapy and placebo - To compare medication adherence with niacin therapy and placebo. ;Primary end point(s): To evaluate the reduction of cardiovascular events by niacin in patients with elevated Lp(a) levels. | — |
Countries
Germany
Outcome results
None listed