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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: losartan potassium (+) hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Neuropsychological tests and blood pressure after treatment of 12 weeks


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.


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


- Diagnosed with major depression when entering the study

- Foreign language as his or her mother tongue so that the test results will not be


- 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

Locations and Contacts

Additional Information

Starting date: March 2005
Last updated: July 3, 2014

Page last updated: August 23, 2015

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