Effect of Niacin in the Lipoprotein (a) Concentration

This study has been completed.
Sponsor:
Collaborator:
Hospital Miguel Servet
Information provided by (Responsible Party):
Fernando Civeira, Instituto Aragones de Ciencias de la Salud
ClinicalTrials.gov Identifier:
NCT01321034
First received: March 22, 2011
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Hypercholesterolemia
Drug: Niacin/Laropiprant
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Instituto Aragones de Ciencias de la Salud:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 ).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT01321034

Locations
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
Principal Investigator: Fernando Civeira, MD Hospital Miguel Servet
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: EudraCT 2010-022258-17
Study First Received: March 22, 2011
Last Updated: January 8, 2013
Health Authority: Spain: Sudirección General de Medicamentos de Uso Humano

Keywords provided by Instituto Aragones de Ciencias de la Salud:
Lipoprotein (a)
LPA
Niacin
Kringle IV-2 repeats

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
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