Hyzaar Asia HEAALTH (0954A-950)

NCT ID: NCT00354991

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

437 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-01

Study Completion Date

2007-04-01

Brief Summary

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The objective of the study is to estimate the percentage of patients who reach blood pressure goal after 8 weeks of treatment with losartan/HCTZ combination.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Losartan/HCTZ

Group Type EXPERIMENTAL

losartan potassium (+) hydrochlorothiazide

Intervention Type DRUG

Patients took losartan 50 mg /HCTZ 12.5 mg orally once daily for 13 weeks. At Weeks 0, 4 and 8 if the blood pressure goal was not reached then the losartan/HCTZ combination will be titrated upwards according to the following scheme: losartan 50/HCTZ 12.5 to losartan 100/HCTZ 12.5 to losartan 100/HCTZ 25.

Interventions

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losartan potassium (+) hydrochlorothiazide

Patients took losartan 50 mg /HCTZ 12.5 mg orally once daily for 13 weeks. At Weeks 0, 4 and 8 if the blood pressure goal was not reached then the losartan/HCTZ combination will be titrated upwards according to the following scheme: losartan 50/HCTZ 12.5 to losartan 100/HCTZ 12.5 to losartan 100/HCTZ 25.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient is male or female and = 18 years of age
* Patients with essential hypertension previously treated with antihypertensive medications for at least 4 weeks but did not reach the blood pressure goal

Exclusion Criteria

* History of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient/subject to participate
* Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
* Previous history of severe essential hypertension
* History of stroke or myocardial infarction (heart attack)
* Evidence of renal or liver disease
* Uncontrolled diabetes mellitus
* Any known bleeding disorder
* Known sensitivity or intolerance to the study medication (losartan or hydrochlorothiazide)
* Other antihypertensive medications or medications that may affect blood pressure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Kim KS, Fan WH, Kim YD, Zhu W, Ngau YY, Tong P, Kim BS, Santos M, Lin WH, Buranakitjaroen P, Massaad R, Smith RD; Asia HEAALTH Study Investigators. Effectiveness of open-label losartan/hydrochlorothiazide combination therapy in Asian patients with hypertension not controlled with ACE inhibitor or ARB monotherapy. Hypertens Res. 2009 Jun;32(6):520-6. doi: 10.1038/hr.2009.42. Epub 2009 Apr 24.

Reference Type DERIVED
PMID: 19390542 (View on PubMed)

Study Documents

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Document Type: CSR Synopsis

View Document

Related Links

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http://www.merck.com/clinical-trials/policies-perspectives.html

Click here to access a synopsis of the study results.

Other Identifiers

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MK0954A-950

Identifier Type: -

Identifier Source: secondary_id

2006_012

Identifier Type: -

Identifier Source: secondary_id

0954A-950

Identifier Type: -

Identifier Source: org_study_id

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