Evaluation of the Antihypertensive Effect of Hyzaar(R) an... | NCT00398541

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

NCT00398541

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

41Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

losartan potassium (+) hydrochlorothiazide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2005Actual

Primary Completion Date

Apr 10, 2007Actual

Completion Date

Jun 1, 2007Actual

First Submitted Date

Nov 9, 2006

First Submission Date that Met QC Criteria

Nov 9, 2006

First Posted Date

Nov 10, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2024

Last Update Posted Date

Aug 15, 2024Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
losartan potassium (+) hydrochlorothiazide	Drug	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		MK954A Hyzaar

Measure	Description	Time Frame
Neuropsychological tests and blood pressure after treatment of 12 weeks		after treatment of 12 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Type	Description	Link
MK0954A-322
2006_048