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Sponsored by: |
Charite University, Berlin, Germany |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00633698 |
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 |
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Elevated Lipoprotein(a) Levels |
Drug: Nicotinic acid (niacin) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Effect of NICOtinic Acid (Niacin) on Elevated Lipoprotein(a) Levels (NICOLa Study) |
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 |
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1: Active Comparator
Nicotinic acid (niacin)
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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
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2: Placebo Comparator
Placebo
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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
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Institute of Social Medicine, Epidemiology and Health Economics | |
Berlin, Germany, 10098 |
Study Director: | Elisabeth Steinhagen-Thiessen, MD | Lipidambulanz und Lipidapherese, Charité Campus Virchow-Klinikum |
Responsible Party: | Charité University Medical Center, Berlin, Germany ( Prof. Dr. Elisabeth Steinhagen-Thiessen ) |
Study ID Numbers: | Ep_Li 001_2006, EudraCT No.: 2006-005710-12 |
Study First Received: | March 5, 2008 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00633698 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
lipoprotein(a) niacin placebo intervention |
Antimetabolites Vasodilator Agents Niacinamide Vitamin B Complex Antilipemic Agents Trace Elements Cardiovascular Agents |
Nicotinamide Nicotinic Acids Vitamin B3 Vitamins Micronutrients Nicotinic Acid Niacin |
Antimetabolites Vasodilator Agents Niacinamide Vitamin B Complex Molecular Mechanisms of Pharmacological Action Growth Substances Antilipemic Agents Physiological Effects of Drugs |
Cardiovascular Agents Pharmacologic Actions Nicotinic Acids Therapeutic Uses Vitamins Micronutrients Niacin |