Antihypertensive Response to Losartan and Genetic Polymorphisms

NCT00617877 | Completed

• 2 other identifiers: 2007_035MK0954-334
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood pressure reduction with reference to genetic polymorphisms.

  Over 1 Year

Study Arms (1)

1

EXPERIMENTAL

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; Drug: Comparator: Hydrochlorothiazide

Interventions

losartan potassium 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).

1

Comparator: Hydrochlorothiazide 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).

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hypertension

Interventions

Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 18, 2008
• Study Start: March 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 22, 2009

Record last verified: 2009-07