Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01321034
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2011-03-22
Brief Title:
Effect of Niacin in the Lipoprotein a Concentration
Sponsor:
Instituto Aragones de Ciencias de la Salud
Organization:
Instituto Aragones de Ciencias de la Salud
Study Overview
Official Title:
Effect of Niacin in the Lipoprotein a Concentration With Regard to Apolipoprotein a Size and Baseline Lipoprotein a Concentration
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
To evaluate the absolute and relative Lpa lowering effect of 1g20 mg and 2 g40 mg day of NiacinLaropiprant in subjects with normal Lpa 30 mgdL high Lpa 30-60 mgdL and very high Lpa 60 mgdL
To evaluate the absolute and relative Lpa lowering effect of 1g20 mg and 2 g40 mg day of NiacinLaropiprant depending on the number of kringle IV-2 repeated copies on the apoa gene 211 Hypotheses
The Lpa lowering effect of niacin is dependent of the pre-treatment Lpa concentration with higher absolute and relative reduction in Lpa in subjects with hyperlipoproteinemiaa
Lpa size throughout modifying hepatic synthesis of apoa is a major factor related to the lowering effect variability of niacin in human
To evaluate the absolute and relative Lpa lowering effect of 1g20 mg and 2 g40 mg day of NiacinLaropiprant in subjects with normal Lpa 30 mgdL high Lpa 30-60 mgdL and very high Lpa 60 mgdL
To evaluate the absolute and relative Lpa lowering effect of 1g20 mg and 2 g40 mg day of NiacinLaropiprant depending on the number of kringle IV-2 repeated copies on the apoa gene 211 Hypotheses
The Lpa lowering effect of niacin is dependent of the pre-treatment Lpa concentration with higher absolute and relative reduction in Lpa in subjects with hyperlipoproteinemiaa
Lpa size throughout modifying hepatic synthesis of apoa is a major factor related to the lowering effect variability of niacin in human
Detailed Description:
Open-label 12-week study 1g20 mg day of NiacinLaropiprant for 4-weeks followed by 8 additional weeks of 2 g40 mg day Subjects with normal Lpa 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 Lpaconcentration 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 Lpa 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 apoa genetic polymorphism responsible of the Lpa size variability will be analyzed by a PCR-based methodology Lanktree et al J Lipid Res 2009 50 768-72
Subjects volunteers from the Lipid Clinic of Hospital Universitario Miguel Servet of Zaragoza Spain Subjects were selected according to their previously determined Lpaconcentration 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 Lpa 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 apoa genetic polymorphism responsible of the Lpa size variability will be analyzed by a PCR-based methodology Lanktree et al J Lipid Res 2009 50 768-72
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None