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
  Purpose

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
Hypertension

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA

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


Enrollment: 43
Study Start Date: April 2006
Study Completion Date: February 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   22 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hypertension patients living in Taiwan

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728858

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: FU-TIEN CHIANG, Doctor National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00728858     History of Changes
Other Study ID Numbers: 941227
Study First Received: May 28, 2008
Last Updated: August 1, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Hypertension
SNP
Nifedipine
Barnidipine

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014