The Efficacy, Safety and Genetic Polymorphism of Hypoca and Adalat OROS in Hypertensive Patients
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||An Open-Label, Randomized Clinical Study to Evaluate the Efficacy, Safety and Genetic Polymorphism of Hypoca(Barnidipine)and Adalat OROS(Nifedipine) in Mild to Moderate Hypertensive Patients|
Extract DNA from buffy coat. Test drug concentration in plasma.
|Study Start Date:||April 2006|
|Study Completion Date:||February 2007|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
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 1.2 will be genotyped using SNPstream.
The differences in the decrease of blood pressures and the durg plasma concentrations between genotypes will be analyzed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728858
|Study Chair:||FU-TIEN CHIANG, Doctor||National Taiwan University Hospital|