Effect of Niacin in the Lipoprotein (a) Concentration
This study has been completed.
Sponsor:
Instituto Aragones de Ciencias de la Salud
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
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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:
- Age >18 and < 80 years
- LDL cholesterol between 70 and 190 mg/dL
- Triglycerides < 500 mg/dL
- At least 2 Lp(a) determinations previous to the beginning of the study without differences >20% or > 20 mg/dL.
- No lipid lowering therapy or on stable doses in the last 3 months
Exclusion Criteria:
- Liver disease or liver enzymes >2 times higher than reference values
- Creatinine > 2 mg/dL
- Active peptic ulcer
- Clinical gout in the last year
- Uncontrolled diabetes (HbA1c >8%)
- Enrolment in other drug clinical trial in the previous 3 months.
Contacts and Locations
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 Vasodilator Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013