Antihypertensive Response to Losartan and Genetic Polymorphisms - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00617877

Purpose

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

Condition	Intervention
Hypertension	Drug: losartan potassium Drug: Comparator: Hydrochlorothiazide

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pharmacogenetic of the Antihypertensive Response to the Angiotensin II Blockers in Monotherapy or Associated to Hydrochlorothiazide

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure Potassium

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Blood pressure reduction with reference to genetic polymorphisms. [ Time Frame: Over 1 Year ] [ Designated as safety issue: No ]

Enrollment:	800
Study Start Date:	March 2005
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617877

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00617877 History of Changes
Other Study ID Numbers:	2007_035, MK0954-334
Study First Received:	February 5, 2008
Last Updated:	July 21, 2009
Health Authority:	Italy: Ministry of Health

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hydrochlorothiazide
Losartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012