icotinic Acid and Lipoprotein (a): The Effect of Extended Release Nicotinic Acid on Plasma Lipoprotein (a), its Isoforms and apo(a) Fragments

Phase 3

• Conditions: Hyperlipidemia; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12611000252910
• Lead Sponsor: A/Prof. K.Kostner

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Approximately 30 participants will be recruited for this study.
As per the protocol all participants will have elevated Lipoprotein (a), already be taking lipid lowering medication, and be either male or female between 18 and 75 years of age. It is expected that the ratio of recruitment will be unbalanced (male (60%) to female (40%) purely due to the incidence of disease in the community.

Exclusion Criteria

Children are excluded for legal reasons and pregnant women are excluded due to safety considerations to the unborn.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary hypothesis is that ERN decreases plasma concentrations of both high and low molecular weight isoforms of apo by:<br>a)decreasing the synthesis rate of apo(a) <br>b)decrease of apo(a) transcription <br>c)decreasing the assembly of Lp(a)<br><br>This will be asessed by plasma and urine assays for Lp(a) and apo(a) isoforms[1,2 and 4 and 12 weeks.]

Secondary Outcome Measures

Name	Time	Method
The secondary hypothesis is that ERN decreases plasma concentrations of both high and low molecular isoforms of apo by increasing urinary apo(a) secretion.<br><br>This will be asessed by plasma and urine assays for Lp(a) and apo(a) isoforms[1,2 and 4 and 12 weeks.]