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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Losartan 50 mg / HCTZ 12.5 mg

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: MK-0954A

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Organon and Co
• Investigators: Principal Investigator: Du-Yi Lee, M.D., Cheng Ching General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: September 7, 2011
• First Submitted That Met QC Criteria: September 8, 2011
• First Posted (Estimate): September 9, 2011

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan
• Other Study ID Numbers: 0954A-373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php