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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00398541

Enrollment

Registered

2006-11-10

Start date

2005-03-01

Completion date

2007-06-01

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Interventions

DRUGlosartan potassium (+) hydrochlorothiazide

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Neuropsychological tests and blood pressure after treatment of 12 weeks	after treatment of 12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026