Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients (0954A-322)

Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM).

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ACEi or ARB naive or not taking ACEi or ARB concurrently for at least one month before the run-in period
Be able to carry out his or her own daily activity
- Be at least 50 years old at inclusion in the study Be diagnosed with mild to moderate hypertension, treated or untreated
Literate
Not taking any cognitive-enhanced agent at baseline
Present with a memory complain ( spontaneous or informed by caregiver)

Exclusion criteria

Congestive heart failure with NYHA class >2
Renal failure or renal insufficiency with serum creatinine >1.4mg/dl
chronic severe liver disease with abnormal GPT and GOT >2 times of upper normal limits
Diagnosed with major depression when entering the study
Foreign language as his or her mother tongue so that the test results will not be reliable
History of stroke or transient ischemic attack (stroke is defined as focal neurological sign progressing stepwise)
Hypersensitive to the active ingredient and any other component of losartan potassium and indapamide tablets
Major hearing loss/deafness and/or major visual impairment/blindness preventing from performing the tests
Myocardial infarction within the past 6 months
Single functioning kidney
Anuria

Treatment and study plan

losartan potassium (+) hydrochlorothiazide

Drug

losartan potassium (+) hydrochlorothiazide combination will be titrated upwards according to the following scheme: losartan potassium 50/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 25

Other names: MK954A, Hyzaar

Primary outcomes

Neuropsychological tests and blood pressure after treatment of 12 weeks

Time frame: after treatment of 12 weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Nov 10, 2006
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed