Status:
COMPLETED
A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3)
Lead Sponsor:
Organon and Co
Conditions:
Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
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 hyp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01431508
Start Date
August 1 2007
End Date
June 1 2009
Last Update
May 22 2024
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