Antihypertensive Response to Losartan and Genetic Polymorphisms

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Drug: losartan potassium

• Registration Number: NCT00617877
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-18
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-21
• Last Update Posted: 2009-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	losartan 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. HCTZ 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).

Primary Outcome Measures

Name	Time	Method
Blood pressure reduction with reference to genetic polymorphisms.	Over 1 Year