Overview

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

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
Summary
Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Antihypertensive Agents
Hydrochlorothiazide
Losartan
Criteria
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