Hyzaar Asia HEAALTH (0954A-950)

An Open Label Study to Assess the Efficacy of Losartan/HCTZ Combination Therapy in Patients With Essential Hypertension Who Were Inadequately Controlled on Current Antihypertensive Monotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00354991

Enrollment

437

Registered

2006-07-20

Start date

2006-06-01

Completion date

2007-04-01

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

Interventions

DRUGlosartan 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients reaching a blood pressure goal (diastolic <90mm Hg for non-diabetics; <80mm Hg for diabetics) after 8 weeks of treatment	8 Weeks

Secondary

Measure	Time frame
Safety and tolerability	13 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026