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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00728858
First received: May 28, 2008
Last updated: August 1, 2008
Last verified: April 2008

May 28, 2008
August 1, 2008
April 2006
December 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00728858 on ClinicalTrials.gov Archive Site
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The Efficacy, Safety and Genetic Polymorphism of Hypoca and Adalat OROS in Hypertensive Patients
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Extract DNA from buffy coat. Test drug concentration in plasma.

Probability Sample

Hypertension patients living in Taiwan

Hypertension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
February 2007
December 2006   (final data collection date for primary outcome measure)

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
Both
22 Years to 87 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00728858
941227
Yes
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Study Chair: FU-TIEN CHIANG, Doctor National Taiwan University Hospital
National Taiwan University Hospital
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP