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Evaluation of the Effect of NICOtinic Acid (Niacin) on Elevated Lipoprotein(a) Levels (NICOLa Study) (NICOLa)

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ClinicalTrials.gov Identifier: NCT00633698
Recruitment Status : Unknown
Verified August 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : March 12, 2008
Last Update Posted : August 4, 2009
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
Lipoprotein (Lp)(a) has been associated with increased risk of cardiovascular disease. Niacin has been shown to lower Lp(a) in patients with normal or moderately elevated levels. However, there are few studies assessing the effectiveness of niacin in Lp(a) levels above 30 mg/dl. In addition, most studies investigating the effectiveness of niacin have only included small numbers of patients. Also, Lp(a) was only assessed as a secondary endpoint. The aim of the present study was, therefore, to evaluate whether Niacin is effective compared to placebo in the reduction of an elevated Lp(a).

Condition or disease Intervention/treatment Phase
Elevated Lipoprotein(a) Levels Drug: Nicotinic acid (niacin) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of NICOtinic Acid (Niacin) on Elevated Lipoprotein(a) Levels (NICOLa Study)
Study Start Date : January 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Nicotinic acid (niacin)
Drug: Nicotinic acid (niacin)
oral medication Week 1-4: 500 mg per day Week 5-8: 1000 mg per day Week 9-12: 1500 mg per day Week 13-20: 2000 mg per day
Other Name: Niaspan

Placebo Comparator: 2
Drug: Placebo
Placebo Week 1-4: 500 mg per day Week 5-8: 1000 mg per day Week 9-12: 1500 mg per day Week 13-20: 2000 mg per day

Primary Outcome Measures :
  1. Mean change in Lp(a) levels [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Mean change in total cholesterol levels [ Time Frame: 20 weeks ]
  2. Mean change in LDL (low density lipoprotein) cholesterol levels [ Time Frame: 20 weeks ]
  3. Mean change in HDL (high density lipoprotein) cholesterol levels [ Time Frame: 20 weeks ]
  4. Mean change in triglyceride levels [ Time Frame: 20 weeks ]
  5. Mean change in blood glucose levels [ Time Frame: 20 weeks ]
  6. Health-related quality of life [ Time Frame: 20 weeks ]
  7. Disease-related costs [ Time Frame: 20 weeks ]
  8. Clinical adverse events [ Time Frame: 20 weeks ]
  9. Laboratory safety parameters [ Time Frame: 20 weeks ]
  10. Adherence to medication [ Time Frame: 20 weeks ]
  11. Tolerability of medication [ Time Frame: 20 weeks ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects, aged 18 - 75 years
  • Subjects with and without cardiovascular diseases
  • Lp(a) plasma levels > 30 mg/dl
  • Triglyceride levels < 400 mg/dl
  • Cholesterol and triglyceride levels not requiring immediate change in medication according to current clinical guidelines
  • If concurrent statin therapy, stable doses are required in the four weeks prior study inclusion, and no changes in statin dosages are allowed during the study period
  • Subjects willing to follow all study procedures including attendance at practices for scheduled study visits, fasting prior to blood draws and compliance with study treatment regimen
  • Written informed consent to participate in the trial

Exclusion Criteria:

  • Known hypertriglyceridaemia or fasting triglycerides >= 400 mg/dl in the last four weeks before the randomisation visit.
  • Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
  • Documented secondary hypercholesterolaemia of any cause
  • Initiation of a lipid-modifying drug treatment or a dose change of a lipid-modifying drug within the last four weeks
  • Known hypersensitivity to nicotinic acid or any component of this medication or their derivatives
  • Concurrent treatment with products containing significant amounts (more than 100 mg as daily dose) of nicotinic acid (niacin) or nicotinamide (e.g., vitamin preparations and nutritional supplements)
  • Concurrent treatment with an immediate release formulation of nicotinic acid or a nicotinic acid analogue, e.g. supplements
  • Treatment with an anticoagulant such as marcumar
  • Cardiovascular diseases which are contra-indicated: unstable angina, acute myocardial infarction or uncontrolled cardiac arrhythmias within the preceding 3 months, stroke within the preceding 6 months, symptomatic heart failure (NYHA class III or IV), or severe peripheral artery disease
  • Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception (prescription oral contraceptives, abstinence, condoms with spermicide, surgical sterilisation, diaphragm with spermicide, or intrauterine device)
  • History of malignancy, except subjects who have been disease free for more than 10 years or whose only malignancy has been basal or squamous cell skin carcinoma. Women with a history of cervical dysplasia should be excluded unless 3 consecutive normal cervical smears have subsequently been recorded before entry into the study.
  • History of alcohol (more than 2 glasses of wine or alcohol equivalent per day) or drug abuse (within 12 months of screening), or both
  • Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT >=1.5 times the ULN in the last 4 weeks before the randomisation visit
  • Known uncontrolled or poorly controlled (HbA1C > 9 %) diabetes
  • Persistent uncontrolled or untreated hypertension, defined as either resting diastolic blood pressure of > 95 mmHg or resting systolic blood pressure of > 200 mmHg
  • Unexplained serum creatine phosphokinase (CK) > 3 times the ULN in the last 4 weeks before the randomisation visit (e.g. not due to recent trauma, intramuscular injections, heavy exercise etc)
  • 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 (serum creatinine > 1.5 mg/dl)
  • 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 that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
  • Persons who are detained officially or legally to an official institution.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633698

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Institute of Social Medicine, Epidemiology and Health Economics
Berlin, Germany, 10098
Sponsors and Collaborators
Charite University, Berlin, Germany
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Study Director: Elisabeth Steinhagen-Thiessen, MD Lipidambulanz und Lipidapherese, Charité Campus Virchow-Klinikum
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Responsible Party: Prof. Dr. Elisabeth Steinhagen-Thiessen, Charité University Medical Center, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00633698    
Other Study ID Numbers: Ep_Li 001_2006
EudraCT No.: 2006-005710-12
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: August 4, 2009
Last Verified: August 2009
Keywords provided by Charite University, Berlin, Germany:
Additional relevant MeSH terms:
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Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Physiological Effects of Drugs