Antihypertensive Response to Losartan and Genetic Polymorphisms

NCT ID: NCT00617877

Last Updated: 2009-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2009-06-30

Brief Summary

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

Conditions

Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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).

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: DRUG

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).

Comparator: Hydrochlorothiazide

Intervention Type: DRUG

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).

Interventions

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.) Continued until the end of the study (visit 9-week 48).

Intervention Type: DRUG

Comparator: 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).

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Merck & Co., Inc.

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0954-334

Identifier Type: -

Identifier Source: secondary_id

2007_035

Identifier Type: -

Identifier Source: org_study_id