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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: November 9, 2006
Last updated: September 23, 2015
Last verified: September 2015
Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM).

Condition Intervention Phase
Hypertension Drug: losartan potassium (+) hydrochlorothiazide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Neuropsychological tests and blood pressure after treatment of 12 weeks [ Time Frame: after treatment of 12 weeks ]

Enrollment: 41
Study Start Date: March 2005
Study Completion Date: June 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Names:
    • MK954A
    • Hyzaar

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00398541

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00398541     History of Changes
Other Study ID Numbers: 0954A-322
Study First Received: November 9, 2006
Last Updated: September 23, 2015

Additional relevant MeSH terms:
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on June 23, 2017