Antihypertensive Response to Losartan and Genetic Polymorphisms
Information source: Merck
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Losartan (Drug); Hydrochlorothiazide (Drug)
Phase: Phase 4
Sponsored by: Merck
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
The purpose of this study is to evaluate the antihypertensive response of treatment with
losartan with reference to genetic polymorphisms.
Official title: Pharmacogenetic of the Antihypertensive Response to the Angiotensin II Blockers in Monotherapy or Associated to Hydrochlorothiazide
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Blood pressure reduction with reference to genetic polymorphisms.
Minimum age: 18 Years.
Maximum age: 60 Years.
- 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.
- 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 know hypersensibility to study drug(s)
Locations and Contacts
Merck Sharp & Dohme (Italia) S.P.A., Roma 191, Italy; Recruiting
Gianfranco Botta, Phone: 39 06 36 191187
(MedWatch - FDA maintained medical product safety Information)
(PhRMA Clinical Study Results Database - web-based repository for clinical study results)
(Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: March 2005
Last updated: August 6, 2008