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CompletedNCT00354991Updated May 9, 2017

Hyzaar Asia HEAALTH (0954A-950)

A Phase 3 interventional study of losartan potassium (+) hydrochlorothiazide in Hypertension, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
437
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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 437 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
437 participants (actual)

Study arms

  • Experimental
    1

    Losartan/HCTZ

    Drug: losartan potassium (+) hydrochlorothiazide

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.

06

What researchers measure

Primary outcomes

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

    Time frame: 8 Weeks

Secondary outcomes

  1. Safety and tolerability

    Time frame: 13 Weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 19390542 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00354991
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jul 20, 2006
Start date
Jun 1, 2006
Primary completion
Apr 1, 2007
Completion
Apr 1, 2007
Last update
May 9, 2017

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 May 2017. You cannot join it, but the record below documents what was studied.

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