Hyzaar Asia HEAALTH (0954A-950)

NCT00354991 | Completed Phase 3

• 3 other identifiers: 0954A-950MK0954A-9502006_012
• Study Type: interventional
• Target: 437
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

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

  8 Weeks

Secondary Outcomes (1)

• Safety and tolerability

  13 Weeks

Study Arms (1)

1

EXPERIMENTAL

Losartan/HCTZ

Drug: losartan potassium (+) hydrochlorothiazide

Interventions

losartan potassium (+) hydrochlorothiazide 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 19390542 DERIVED

Related Links

• Click here to access a synopsis of the study results.

MeSH Terms

Conditions

Hypertension

Interventions

hydrochlorothiazide, losartan drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 20, 2006
• Study Start: June 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: May 9, 2017

Record last verified: 2017-05