Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000252910
Ethics application status
Approved
Date submitted
3/03/2011
Date registered
8/03/2011
Date last updated
8/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Nicotinic Acid and Lipoprotein (a): The Effect of Extended Release Nicotinic Acid on Plasma Lipoprotein (a), its Isoforms and apo(a) Fragments
Scientific title
Effect Of Extended Release Nicotinic Acid On Plasma Lipoprotein (a), Its Isoforms And Apo(a) Fragments.
Secondary ID [1] 259738 0
n.a.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperlipidemia 261304 0
Condition category
Condition code
Cardiovascular 259451 259451 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Extended release niacin

dose: 2g once daily
duration of administration: 8 weeks
mode of administration: oral capsule
Intervention code [1] 264150 0
Treatment: Drugs
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262262 0
The primary hypothesis is that ERN decreases plasma concentrations of both high and low molecular weight isoforms of apo by:
a) decreasing the synthesis rate of apo(a)
b) decrease of apo(a) transcription
c) decreasing the assembly of Lp(a)

This will be asessed by plasma and urine assays for Lp(a) and apo(a) isoforms
Timepoint [1] 262262 0
1,2 and 4 and 12 weeks.
Secondary outcome [1] 273418 0
The secondary hypothesis is that ERN decreases plasma concentrations of both high and low molecular isoforms of apo by increasing urinary apo(a) secretion.

This will be asessed by plasma and urine assays for Lp(a) and apo(a) isoforms
Timepoint [1] 273418 0
1,2 and 4 and 12 weeks.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children are excluded for legal reasons and pregnant women are excluded due to safety considerations to the unborn.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
subjects will be recruited in cardiology and lipids outpatient clinics
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264604 0
Commercial sector/Industry
Name [1] 264604 0
MSD
Country [1] 264604 0
Australia
Primary sponsor type
Individual
Name
A/Prof. K.Kostner
Address
Mater Adult Hospital, Raymond Terrace 100 , 4101 Qld, Brisbane, Australia
Country
Australia
Secondary sponsor category [1] 263744 0
None
Name [1] 263744 0
Address [1] 263744 0
Country [1] 263744 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260599 0
University of Queensland
Ethics committee address [1] 260599 0
Cumbrae-Stewart Building , Research Road 1, 4072 Qld, Brisbane, Australia
Ethics committee country [1] 260599 0
Australia
Date submitted for ethics approval [1] 260599 0
Approval date [1] 260599 0
02/03/2011
Ethics approval number [1] 260599 0
2011000136

Summary
Brief summary
Lipoprotein(a) [Lp(a)] is one of the most atherogenic lipoproteins and consists of a glycoprotein called apo(a) which is covalently linked to an LDL particle. Lp(a) is mostly synthesized in the liver and metabolized both via the kidney and liver. A size polymorphism of apo(a) (high and low molecular weight isoforms) exists that negatively correlates with plasma Lp(a) levels. We could previously show that fragments of apo(a) are secreted into the urine and the daily secretion rate correlates with plasma Lp(a) concentrations. Nicotinic acid (NA) and extended release nicotinic acid (ERN) are currently the only lipid lowering drugs that consistently reduce plasma Lp(a) by up to 30%. Since the mechanism by which ERN lowers Lp(a) is not entirely clear we aim to investigate this mechanism in vivo and in vitro.
Trial website
none
Trial related presentations / publications
none yet
Public notes

Contacts
Principal investigator
Name 32306 0
Address 32306 0
Country 32306 0
Phone 32306 0
Fax 32306 0
Email 32306 0
Contact person for public queries
Name 15553 0
A/Prof. Karam Kostner
Address 15553 0
Mater Adult Hospital, Cardiology Department
Raymond TCE 100, 4101, Brisbane, Australia
Country 15553 0
Australia
Phone 15553 0
+61 7 31636793
Fax 15553 0
+617 31636750
Email 15553 0
[email protected]
Contact person for scientific queries
Name 6481 0
A/Prof. K.Kostner
Address 6481 0
Mater Adult Hospital, Cardiology Department
Raymond TCE 100, 4101, Brisbane, Australia
Country 6481 0
Australia
Phone 6481 0
+61 7 31636793
Fax 6481 0
+61 7 31636750
Email 6481 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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