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

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ClinicalTrials.gov Identifier: NCT00728858
Recruitment Status : Completed
First Posted : August 6, 2008
Last Update Posted : August 6, 2008
Sponsor:
Information provided by:
National Taiwan University Hospital

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
Hypertension

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 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 : April 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine
U.S. FDA Resources




Biospecimen Retention:   Samples With DNA
Extract DNA from buffy coat. Test drug concentration in plasma.


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 87 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728858


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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00728858     History of Changes
Other Study ID Numbers: 941227
First Posted: August 6, 2008    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: April 2008

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs