Clincosm LogoSign in Get a demo

The Efficacy, Safety and Genetic Polymorphism of Hypoca and Adalat OROS in Hypertensive Patients

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00728858
Collaborator
(none)
43
Enrollment
10.1
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    43 participants
    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
    Study Start Date :
    Apr 1, 2006
    Actual Primary Completion Date :
    Dec 1, 2006
    Actual Study Completion Date :
    Feb 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      22 Years to 87 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • 20~90 years old patient

      • mild to moderate hypertensive patients

      • can finish this study

      • can sign agreement

      Exclusion Criteria:

      • severe hypertension

      • Heart failure, Arrhythmia

      • Liver or kidney failure

      • pregnant women

      • allergy to dihydropyridines

      • attend other clinical trials in past 3 month

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • National Taiwan University Hospital

      Investigators

      • Study Chair: FU-TIEN CHIANG, Doctor, National Taiwan University Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00728858
      Other Study ID Numbers:
      • 941227
      First Posted:
      Aug 6, 2008
      Last Update Posted:
      Aug 6, 2008
      Last Verified:
      Apr 1, 2008
      Keywords provided by , ,
      Hypertension
      SNP
      Nifedipine
      Barnidipine
      Additional relevant MeSH terms:
      Hypertension

      Study Results

      No Results Posted as of Aug 6, 2008