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OpenTrials
Completed

NCT Number: NCT00728858

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

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Key information

Age range

22 year–87 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Aug 6, 2008
Registry last updated
Aug 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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