Effect of Niacin in the Lipoprotein (a) Concentration

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Instituto Aragones de Ciencias de la Salud
• Collaborator: Hospital Miguel Servet
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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.