MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)

A Phase III, Randomized, Active-comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954A in Japanese Patients With Essential Hypertension Uncontrolled With the High Dose of Losartan Potassium

This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo to MK-0954A; Drug: MK-0954A; Drug: Placebo to losartan 100 mg; Drug: Placebo to losartan 50 mg; Drug: Losartan

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Participant has a diagnosis of essential hypertension.
• Participant is not treated with antihypertensive medication and meets protocol-specified blood pressure criteria.
• Participant is treated with single antihypertensive medication, and meets protocol-specified blood pressure criteria.
• Participant is being treated with up to dual oral antihypertensive medications, and will be able to discontinue the prior antihypertensive medication.
• Participant has no clinically meaningful findings to be disqualified from the study at the discretion of the investigator.

Exclusion criteria:

• Regarding hypertension, participant is currently taking > 2 antihypertensive medications.
• Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-lotan or Preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines)
• Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or a recent history within the last year of drug or alcohol abuse or dependence.
• Participant is pregnant or breastfeeding or expecting to conceive or has a positive pregnancy test at the screening visit.
• Participant is currently participating or has participated in a study with an investigational compound (except losartan at any doses) or device within 30 days of signing informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-0954A; Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.	Drug: MK-0954A; Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily; Drug: Placebo to losartan 100 mg; Placebo tablet to match losartan 100 mg, once daily; Drug: Placebo to losartan 50 mg; Placebo tablet to match losartan 50 mg, once daily
Active Comparator: Losartan; Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.	Drug: Placebo to MK-0954A; Placebo tablet to match MK-0954A, once daily; Drug: Placebo to losartan 50 mg; Placebo tablet to match losartan 50 mg, once daily; Drug: Losartan; Tablet containing losartan potassium (100 mg), once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)	Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).	Baseline and Week 8
Percentage of Participants Who Experienced at Least One Adverse Event (AE)		8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)	Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Fujimoto G, Azuma K, Shirakawa M, Hanson ME, Fujita KP. Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension: two randomized, controlled trials. Hypertens Res. 2014 Dec;37(12):1042-9. doi: 10.1038/hr.2014.114. Epub 2014 Jul 3. Erratum In: Hypertens Res. 2014 Dec;37(12):1088.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2011
• Primary Completion (Actual): February 7, 2012
• Study Completion (Actual): February 7, 2012

Study Registration Dates

• First Submitted: March 1, 2011
• First Submitted That Met QC Criteria: March 1, 2011
• First Posted (Estimated): March 2, 2011

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Blood pressure; Essential hypertension; Uncontrolled hypertension; Antihypertensive agents
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential 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-352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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