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Effect of Niacin in the Lipoprotein (a) Concentration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01321034
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : January 10, 2013
Sponsor:
Collaborator:
Hospital Miguel Servet
Information provided by (Responsible Party):
Fernando Civeira, Instituto Aragones de Ciencias de la Salud

Study Description
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Brief Summary:

Objectives.

  • To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant in subjects with normal Lp(a) (< 30 mg/dL), high Lp(a) (30-60 mg/dL) and very high Lp(a) (> 60 mg/dL).
  • To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant depending on the number of kringle IV-2 repeated copies on the apo(a) gene. 2.1.1 Hypotheses.
  • The Lp(a) lowering effect of niacin is dependent of the pre-treatment Lp(a) concentration, with higher absolute and relative reduction in Lp(a) in subjects with hyperlipoproteinemia(a).
  • Lp(a) size, throughout modifying hepatic synthesis of apo(a), is a major factor related to the lowering effect variability of niacin in human.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Niacin/Laropiprant Phase 4

Detailed Description:

Open-label 12-week study, 1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day. Subjects with normal Lp(a) will be use as comparative group for the other two groups, so no placebo group is required is this study.

Subjects: volunteers from the Lipid Clinic of Hospital Universitario Miguel Servet of Zaragoza, Spain. Subjects were selected according to their previously determined Lp(a)concentration. All volunteers before any study procedure will have to give written inform consent to a protocol previously approved for the Ethical Committees of our institutions.

Biochemical determinations: lipids: total cholesterol and triglycerides; lipoproteins: HDL-cholesterol, Lp(a); apolipoproteins: Apo A1 and apo B and safety biochemical parameters (glucose, uric acid, creatinine, liver and muscle enzymes will be measured at baseline and at the end of the two treatment periods (weeks 4 and 8).

An adverse experience questionnaire will be done in each visit. Genetic analysis: apo(a) genetic polymorphism responsible of the Lp(a) size variability will be analyzed by a PCR-based methodology (Lanktree et al. J Lipid Res 2009; 50: 768-72 ).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Niacin in the Lipoprotein (a) Concentration With Regard to Apolipoprotein (a) Size and Baseline Lipoprotein (a) Concentration.
Study Start Date : October 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Niacin/Laropiprant
Subjects with normal Lp(a) will be use as comparative group for the other two groups, so no placebo group is required is this study
 Drug: Niacin/Laropiprant
1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day.


Outcome Measures
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Primary Outcome Measures :
  1. absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant in subjects with normal Lp(a) (<30 mg/dL), high Lp(a) (30-60 mg/dL) and very high Lp(a) (>60 mg/dL g/40 mg day of Niacin/Laropiprant [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant depending on the number of kringle IV-2 repeated copies on the apo(a) gene. [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age >18 and < 80 years
  2. LDL cholesterol between 70 and 190 mg/dL
  3. Triglycerides < 500 mg/dL
  4. At least 2 Lp(a) determinations previous to the beginning of the study without differences >20% or > 20 mg/dL.
  5. No lipid lowering therapy or on stable doses in the last 3 months

Exclusion Criteria:

  1. Liver disease or liver enzymes >2 times higher than reference values
  2. Creatinine > 2 mg/dL
  3. Active peptic ulcer
  4. Clinical gout in the last year
  5. Uncontrolled diabetes (HbA1c >8%)
  6. Enrolment in other drug clinical trial in the previous 3 months.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01321034


Locations
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Spain
Hospital San Jorge
Huesca, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Hospital Royo Villanova
Zaragoza, Spain
Sponsors and Collaborators
Instituto Aragones de Ciencias de la Salud
Hospital Miguel Servet
Investigators
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Principal Investigator: Fernando Civeira, MD Hospital Miguel Servet
More Information
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Responsible Party: Fernando Civeira, Chief Lipid Clinic. Hospital Universitario Miguel Servet de Zaragoza, Spain, Instituto Aragones de Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT01321034    
Other Study ID Numbers: EudraCT 2010-022258-17
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013
Keywords provided by Fernando Civeira, Instituto Aragones de Ciencias de la Salud:
Lipoprotein (a)
LPA
Niacin
Kringle IV-2 repeats
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs