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Antihypertensive Response to Losartan and Genetic Polymorphisms

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ClinicalTrials.gov Identifier: NCT00617877
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : July 22, 2009
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment
Hypertension Drug: losartan potassium Drug: Comparator: Hydrochlorothiazide

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacogenetic of the Antihypertensive Response to the Angiotensin II Blockers in Monotherapy or Associated to Hydrochlorothiazide
Study Start Date : March 2005
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).



Primary Outcome Measures :
  1. Blood pressure reduction with reference to genetic polymorphisms. [ Time Frame: Over 1 Year ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617877


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
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
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: July 22, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Hydrochlorothiazide
Losartan
Antihypertensive Agents
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