A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3)

Study Overview
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Brief Summary
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This study is being conducted to evaluate the safety and antihypertensive efficacy of MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to moderate essential hypertension.

Official Title
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An Open-label, Single Arm, Prospective Study to Evaluate the Safety and Anti-hypertensive Efficacy of Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg Combination in Patients With Mild to Moderate Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Losartan 50 mg / HCTZ 12.5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Participant will have reached the legal age by the time of entrance into the run-in period. Participant has no active medical problem, other than essential hypertension, which might of itself or by this treatment significantly affect the Participant's blood pressure. - Participants diagnosed with mild to moderate essential hypertension or hypertension accompanying with established cardiovascular (CV) and renal diseases who are receiving antihypertensive regimen (exclude diuretic), yet not attaining to treatment goal*. * Note: For essential hypertension, the goal is to reduce the blood pressure to less than 140/90. For hypertension with established CV and renal diseases, the BP goal is < 130/80. (According to 2007 European Society of Hypertension (ESH) - European Society of Cardiology (ESC) guideline) Participant is either receiving antihypertensive therapy or no treatment. Participants with stable diabetes mellitus may enter the study. Exclusion criteria: Pregnant or lactating females. Secondary hypertension of any etiology (such as unilateral or bilateral renal disease, renal artery stenosis, coarctation of the aorta, pheochromocytoma). History of malignant hypertension. Sitting systolic blood pressure >210 mmHg at Visit 1 (Day 0). Participants with unresolved cerebrovascular accident or transient ischemic attack in the acute stage at visit 1. A clinically confirmed myocardial infarction within the recent 3 months. Angina pectoris. Clinically important cardiac arrhythmia. History of unexplained syncope within the prior 2 years, or a known syncopal disorder. - Presence of hemodynamically significant obstructive valvular disease of cardiomyopathy. Percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 3 months of visit 1. Participant with a single functioning kidney.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan 50 mg / HCTZ 12.5 mg<br>Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks. | Drug: Losartan 50 mg / HCTZ 12.5 mg<br>* Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks<br>* Other names: MK-0954A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment. | At Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension