Hyzaar Asia HEAALTH - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00354991

Purpose

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
Hypertension	Drug: losartan potassium (+) hydrochlorothiazide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled 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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Merck:

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
1: Experimental Losartan/HCTZ	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354991

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided by Merck

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2009 Apr 24.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_012, MK0954A-950
Study First Received:	July 18, 2006
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00354991 History of Changes
Health Authority:	Thailand: Food and Drug Administration

Additional relevant MeSH terms:

Losartan
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on March 18, 2010