Hyzaar Asia HEAALTH (0954A-950)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: July 18, 2006
Last updated: May 13, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Drug: losartan potassium (+) hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]

Enrollment: 437
Study Start Date: June 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00354991

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00354991     History of Changes
Other Study ID Numbers: 0954A-950  MK0954A-950  2006_012 
Study First Received: July 18, 2006
Last Updated: May 13, 2016
Health Authority: Thailand: Food and Drug Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016