Effect of Niacin in the Lipoprotein (a) Concentration

NCT01321034 | Completed Phase 4 DMC

• 1 other identifier: EudraCT 2010-022258-17
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypercholesterolemia

Keywords

Lipoprotein (a); LPA; Niacin; Kringle IV-2 repeats

Outcome Measures

Primary Outcomes (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

  8 weeks

Secondary Outcomes (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.

  8 weeks

Study Arms (1)

Niacin/Laropiprant

OTHER

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

Interventions

Niacin/Laropiprant DRUG

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

Niacin/Laropiprant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Aragones de Ciencias de la Salud: lead
• Hospital Miguel Servet: collaborator

Study Sites (3)

Hospital San Jorge

Huesca, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Hospital Royo Villanova

Zaragoza, Spain

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Niacin; MK-0524

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Fernando Civeira, MD

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Lipid Clinic. Hospital Universitario Miguel Servet de Zaragoza, Spain

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 23, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

ES (3)