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CompletedNCT00398541Updated Aug 15, 2024

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

A Phase 3 interventional study of losartan potassium (+) hydrochlorothiazide in Hypertension, sponsored by Organon and Co. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Mar 2005, registered Nov 2006).
Phase
Phase 3
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 41 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Interventions

  • Druglosartan 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

    Also known as: MK954A, Hyzaar

06

What researchers measure

Primary outcomes

  1. Neuropsychological tests and blood pressure after treatment of 12 weeks

    Time frame: after treatment of 12 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00398541
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Nov 10, 2006
Start date
Mar 1, 2005
Primary completion
Apr 10, 2007
Completion
Jun 1, 2007
Last update
Aug 15, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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