Evaluation of the effect of NICOtinic acid (niacin) on elevated Lipoprotein(a) levels (NICOLa Study) - NICOLa

Phase 1

• Conditions: ipoprotein (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.

• Registration Number: EUCTR2006-005710-12-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-18
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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 < 400 mg/dl
-Cholesterol and triglyceride levels not requiring immediate change in medication
-If concurrent statin therapy, stable doses are required prior and during the study
-Willingness to follow all study procedures
-Written informed consent
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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>-To compare the effect of niacin therapy on mean change in blood glucose levels to placebo. <br>-To compare the effect of niacin therapy on health-related quality of life (Short Form (SF)-12, EQ-5D)<br>-To compare the effect of niacin therapy on cumulative disease-related costs to placebo.<br>-To compare safety and tolerability in patients with niacin therapy and placebo<br>-To compare medication adherence with niacin therapy and placebo.<br>;Primary end point(s): To evaluate the reduction of cardiovascular events by niacin in patients with elevated Lp(a) levels.