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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: losartan potassium (+) hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00398541

MK0954A-322

0954A-322

2006_048

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)