Antihypertensive Response to Losartan and Genetic Polymorphisms

Pharmacogenetic of the Antihypertensive Response to the Angiotensin II Blockers in Monotherapy or Associated to Hydrochlorothiazide

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00617877

Enrollment

800

Registered

2008-02-18

Start date

2005-03-31

Completion date

2009-06-30

Last updated

2009-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

The purpose of this study is to evaluate the antihypertensive response of treatment with losartan with reference to genetic polymorphisms.

Interventions

DRUGlosartan potassium

Losartan 50 mg/day for 4 weeks, then doubled to losartan 100 mg/day (in case of BP more than 140/90 mm Hg.) Continued until the end of the study (visit 9-week 48).

DRUGComparator: Hydrochlorothiazide

Hydrochlorothiazide 25 mg will be added at week 8 if BP is more than 140/90 mm Hg. This last regimen will be continued until the end of the study (visit 9-week 48).

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Both gender less than 60 years old, with mild-moderate hypertension (SBP greater than and DBP equal or greater than 90 mmhg, BP \< 180/110) * Never treated for hypertension or who have taken antihypertensive agents sporadically (not more than 15 days total therapy) but not in the 30 days prior to the first visit * Patient in therapeutic wash out for 6 months * Patient is asymptomatic, absence of significant concomitant diseases, except for non-familial hypercholesterolemia, absence of systemic diseases * Women with menopause not treated with hormone replacement therapy or women of reproductive age who do not make use of estro-progestagen agents but who use another safe contraceptive method * BMI \< 30 for men and \< 28 for women

Exclusion criteria

* Secondary or malignant hypertension, Na \<130 mmol/l, K \>5,5 mmol/l, or \< 3,0 mmol/l * Cardiac disease such as ischemic, HF, arrhythmia, cardiac surgery * Pregnant, breast feeding * History of nephropathy, metabolic disease, liver disease * Alcohol or drug abuse * History of angioedema * Has a known hypersensibility to study drug(s)

Design outcomes

Primary

Measure	Time frame
Blood pressure reduction with reference to genetic polymorphisms.	Over 1 Year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026