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

NCT00732966 | Unknown

• 1 other identifier: ronit3
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypertension

Keywords

cyp2c9; losartan; pharmacogenetics; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Blood pressure lowering effect of losartan and valsartan in patients with different CYP2C9 allels

  one month

Secondary Outcomes (1)

• losartan/E-3174 ratio in different allelic groups of CYP2C9

  one month

Study Arms (2)

1

EXPERIMENTAL

Hypertensive patients will be treated with losartan for one months

Drug: losartan; Drug: valsartan

2

EXPERIMENTAL

Hypertensive patients will be treated with valsartan

Drug: losartan; Drug: valsartan

Interventions

losartan DRUG

with losartan 50 mg once daily for one month

1; 2

valsartan DRUG

valsartan 160 mg once daily

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

MeSH Terms

Conditions

Hypertension

Interventions

Losartan; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronit Koren Peleg, MD

CONTACT

972-524-535024; ronitkoren@gmail.com

Ahuva Golik, Prof

CONTACT

972-577-345242; golik@asaf.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 10, 2008
• First Posted: August 12, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Last Updated: August 12, 2008

Record last verified: 2008-08