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

Organon and Co336 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

336

Conditions

Hypertension

Interventions

MK-0954ADRUG

Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily

LosartanDRUG

Tablet containing losartan potassium (100 mg), once daily

Placebo to MK-0954ADRUG

Placebo tablet to match MK-0954A, once daily

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Baseline and Week 8

Percentage of Participants Who Experienced at Least One Adverse Event (AE)

Time frame: 8 weeks

Secondary Outcomes

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).

Time frame: Baseline and Week 8

Data from ClinicalTrials.gov

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