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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: losartan 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

Primary Measures

• Neuropsychological tests and blood pressure after treatment of 12 weeks
  • Time Frame: after treatment of 12 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00398541

Study ID Number: 2006_048

ClinicalTrials.gov Identifier: NCT00398541

Health Authority: Taiwan: National Bureau of Controlled Drugs