NCT00398541

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Mar 2005

Typical duration for phase_3 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

2.1 years

First QC Date

November 9, 2006

Last Update Submit

August 13, 2024

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological tests and blood pressure after treatment of 12 weeks

    after treatment of 12 weeks

Interventions

losartan potassium (+) hydrochlorothiazideDRUG

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

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Literate
  • Not taking any cognitive-enhanced agent at baseline
  • Present with a memory complain ( spontaneous or informed by caregiver)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

hydrochlorothiazide, losartan drug combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2006

First Posted

November 10, 2006

Study Start

March 1, 2005

Primary Completion

April 10, 2007

Study Completion

June 1, 2007

Last Updated

August 15, 2024

Record last verified: 2022-02