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

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Organon

Status and phase

Completed
Phase 3

Conditions

Hypertension

Treatments

Drug: losartan potassium (+) hydrochlorothiazide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00398541
MK0954A-322
0954A-322
2006_048

Details and patient eligibility

About

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

Enrollment

41 patients

Sex

All

Ages

50+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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