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.
Summary
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
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: March 2005
Last updated: July 3, 2014
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