Antihypertensive Response to Losartan and Genetic Polymorphisms

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hypertension

Treatments: Drug: Comparator: Hydrochlorothiazide; Drug: losartan potassium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00617877

MK0954-334

2007_035

Details and patient eligibility

About

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

Enrollment: 800 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

1

Experimental group

Description:

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).

Treatment:

Drug: Comparator: Hydrochlorothiazide

Drug: losartan potassium