Effect of Niacin in the Lipoprotein (a) Concentration

NCT ID: NCT01321034

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-12-31

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.

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 ).

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Niacin/Laropiprant

Intervention Type: DRUG

1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day.

Interventions

Niacin/Laropiprant

1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Miguel Servet

OTHER

Sponsor Role: collaborator

Instituto Aragones de Ciencias de la Salud

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fernando Civeira

Chief Lipid Clinic. Hospital Universitario Miguel Servet de Zaragoza, Spain

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando Civeira, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Miguel Servet

Locations

Hospital San Jorge

Huesca, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Hospital Royo Villanova

Zaragoza, , Spain

Countries

Spain

Other Identifiers

EudraCT 2010-022258-17

Identifier Type: -

Identifier Source: org_study_id