Ignite Creation Date:
2024-05-05 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00728858
Status:
COMPLETED
Last Update Posted:
2008-08-06
First Post:
2008-05-28
Brief Title:
The Efficacy Safety and Genetic Polymorphism of Hypoca and Adalat OROS in Hypertensive Patients
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
An Open-Label Randomized Clinical Study to Evaluate the Efficacy Safety and Genetic Polymorphism of HypocaBarnidipineand Adalat OROSNifedipine in Mild to Moderate Hypertensive Patients
Status:
COMPLETED
Status Verified Date:
2008-04
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:
Nifedipine and barnidipine act as calcium channel blockers and are widely prescribed for pressure control of prehypertension and stage 1 hypertension
CYP3A4 is responsible for the metabolism of nifedipine and nifedipine while the contribution of CYP3A5 remains ambiguous This study is aimed to analyze the association between antihypertensive effects of nifedipine as well as barnidipine and single nucleotide polymorphisms of CYP3A4 CYP3A5 and calcium channels
CYP3A4 is responsible for the metabolism of nifedipine and nifedipine while the contribution of CYP3A5 remains ambiguous This study is aimed to analyze the association between antihypertensive effects of nifedipine as well as barnidipine and single nucleotide polymorphisms of CYP3A4 CYP3A5 and calcium channels
Detailed Description:
For each drug 20 patients will be enrolled Patients blood pressure and heart rates will be measured at first visit followed by visits at week4 week 8 and week 12 Blood samples will be drawn at week 4 and week 12 for following analyses of drug plasma concentrations SNPs in CYP3A4 CYP3A5 and calcium channel v 12 will be genotyped using SNPstream
The differences in the decrease of blood pressures and the durg plasma concentrations between genotypes will be analyzed
The differences in the decrease of blood pressures and the durg plasma concentrations between genotypes will be analyzed
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