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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431508
Recruitment Status : Completed
First Posted : September 9, 2011
Results First Posted : November 22, 2011
Last Update Posted : May 5, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Losartan 50 mg / HCTZ 12.5 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 1, 2007
Actual Primary Completion Date : June 1, 2009
Actual Study Completion Date : June 1, 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Losartan 50 mg / HCTZ 12.5 mg
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
Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks
Other Name: MK-0954A

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


- Presence of hemodynamically significant obstructive valvular disease of


  • Percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 3 months of visit 1.
  • Participant with a single functioning kidney.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01431508

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Principal Investigator: Du-Yi Lee, M.D. Cheng Ching General Hospital

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01431508     History of Changes
Other Study ID Numbers: 0954A-373
First Posted: September 9, 2011    Key Record Dates
Results First Posted: November 22, 2011
Last Update Posted: May 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action