Ocsaar and CYP2C9 Ploymorphism, Is There a Connection Between Pharmacokinetics, Pharmacodynamics and Pharmacogenetics?

This study is not yet open for participant recruitment.

Verified by Assaf-Harofeh Medical Center, August 2008

First Received: August 10, 2008 Last Updated: August 11, 2008 History of Changes

Sponsor:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00732966

Purpose

Most Angiotensin receptor blocker's (ARBs) are metabolized by cytochrome P4502C9 (CYP2C9), one of the major isoforms of the cytochrome P450 in human liver microsome. The purpose of this study is to evaluate whether CYP2C9 polymorphism has a significant clinical influence on the blood pressure lowering effect of losartan and valsartan. Weather there is a genetic importance in choosing the right ARB for the right patient.

Condition	Intervention
Hypertension	Drug: losartan Drug: valsartan

Study Type:	Interventional
Study Design:	Open Label, Active Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Ocsaar and CYP2C9 Ploymorphism, Is There a Connection Between Pharmacokinetics, Pharmacodynamics and Pharmacogenetics?

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Losartan Losartan potassium Valsartan

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:

Blood pressure lowering effect of losartan and valsartan in patients with different CYP2C9 allels [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

losartan/E-3174 ratio in different allelic groups of CYP2C9 [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Hypertensive patients will be treated with losartan for one months	Drug: losartan with losartan 50 mg once daily for one month Drug: valsartan valsartan 160 mg once daily
2: Experimental Hypertensive patients will be treated with valsartan	Drug: losartan with losartan 50 mg once daily for one month Drug: valsartan valsartan 160 mg once daily

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The study will include 30 patients with the 3 most prevalent alleles of CYP2C9 *1, *2 and*3, 10 patients of each group.

Exclusion Criteria:

Patients treated with losartan or valsartan prior to their enrollment to the study,
Patients with BP below 140 systolic or 90 diastolic in an ambulatory 24 hours BP monitoring, acute coronary syndrome during the 6 months previous to the study,
Renal failure with creatinin levels above 1.5 mg/dL, hyperkalemia (K > 5 mg/dL),
Hematologic or solid malignancies or pregnancy.
Patients will also be excluded from the study if they are known to use one of the drugs inducing or inhibiting the CYP2C9, such as
- rifampicin carbamazepine,
- ethanol,
- phenobarbitone,
- fluconazole,
- amiodarone,
- trimethoprim,
- fluvastatin,
- cimetidine
- chloramphenicol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732966

Contacts

Contact: Ronit Koren Peleg, MD	972-524-535024	ronitkoren@gmail.com
Contact: Ahuva Golik, Prof	972-577-345242	golik@asaf.health.gov.il

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

Principal Investigator:

Ronit Koren Peleg, MD

Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel

More Information

No publications provided

Responsible Party:	Assaf-Harofeh Medical Center internal medicine A ( Koren Peleg Ronit MD )
Study ID Numbers:	ronit3
Study First Received:	August 10, 2008
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00732966 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:

cyp2c9
losartan
pharmacogenetics
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Losartan
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010