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Completed

NCT Number: NCT01431508

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Losartan 50 mg / HCTZ 12.5 mg

Drug

Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks

Other names: MK-0954A

Primary outcomes

  1. Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12

    Time frame: At Baseline and Week 12

    Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 9, 2011
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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