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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00728858
First Posted: August 6, 2008
Last Update Posted: August 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
May 28, 2008
August 6, 2008
August 6, 2008
April 2006
December 2006   (Final data collection date for primary outcome measure)
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No Changes Posted
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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
Not Provided
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
Sexes Eligible for Study: All
22 Years to 87 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00728858
941227
Yes
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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