Antihypertensive Response to Losartan and Genetic Polymorphisms

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: losartan potassium; Drug: Comparator: Hydrochlorothiazide

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: 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).; 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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: February 5, 2008
• First Submitted That Met QC Criteria: February 5, 2008
• First Posted (Estimate): February 18, 2008

Study Record Updates

• Last Update Posted (Estimate): July 22, 2009
• Last Update Submitted That Met QC Criteria: July 21, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: 2007_035; MK0954-334