The Pharmacokinetics of Nifedipine Controlled Release Tablets in Hypertensive Patients on Hemodialysis
Status:
Unknown status
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
This is a prospective, open, non-randomized, non-controlled study. 20 patients with
hypertension on chronic maintenance hemodialysis will be enrolled in the study. All patients
had mild to moderate hypertension and are receiving antihypertensive agents.
This study was designed to investigate effects of Adalat GITS on hemodialytic blood pressures
in patients with chronic hemodialysis by using ABPM and measuring the drug plasma
concentrations. For the purpose of investigating the influence of hemodialysis on the drug
plasma concentration as well as its efficacy, it should be necessary to assign the subjects
with the Adalat monotherapy. Since most patients in the hemodialysis center will be those who
need and already receive combination therapy, it would be practical to start Adalat 60mg/day
monotherapy to remain similar antihypertensive effect when discontinuing the previous
treatment in this study population to be screened and enrolled. And taking into the
consideration of clinical practice, few patients undergoing hemodialysis could be well
controlled by low dose Adalat 30mg/day alone. So this study will evaluate the effect and
safety of Adalat GITS 60mg/day alone and thereafter the influence of hemodialysis on the drug
plasma concentration without any other possible drug interaction. The agents are given orally
once a day at 08:00h and patients are followed for at least 4 weeks. After that,the patients
whose blood pressure are well controlled by Adalat GITS 60mg/day by office blood pressure
would be enrolled for further ABPM assessment and plasma concentration evaluation.
Phase:
Phase 4
Details
Lead Sponsor:
Guangzhou First Municipal People’s Hospital Guangzhou First People's Hospital