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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00633698
First received: March 5, 2008
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Elevated Lipoprotein(a) Levels
Drug: Nicotinic acid (niacin)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of NICOtinic Acid (Niacin) on Elevated Lipoprotein(a) Levels (NICOLa Study)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Mean change in Lp(a) levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in total cholesterol levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Mean change in LDL (low density lipoprotein) cholesterol levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Mean change in HDL (high density lipoprotein) cholesterol levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Mean change in triglyceride levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Mean change in blood glucose levels [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Disease-related costs [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Clinical adverse events [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory safety parameters [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Adherence to medication [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Tolerability of medication [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633698

Locations
Germany
Institute of Social Medicine, Epidemiology and Health Economics
Berlin, Germany, 10098
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Elisabeth Steinhagen-Thiessen, MD Lipidambulanz und Lipidapherese, Charité Campus Virchow-Klinikum
  More Information

No publications provided

Responsible Party: Prof. Dr. Elisabeth Steinhagen-Thiessen, Charité University Medical Center, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00633698     History of Changes
Other Study ID Numbers: Ep_Li 001_2006, EudraCT No.: 2006-005710-12
Study First Received: March 5, 2008
Last Updated: August 3, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
lipoprotein(a)
niacin
placebo
intervention

Additional relevant MeSH terms:
Niacin
Nicotinic Acids
Niacinamide
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014