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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-29

Study Completion Date

2012-02-07

Brief Summary

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

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK-0954A

Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.

Group Type EXPERIMENTAL

MK-0954A

Intervention Type DRUG

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

Placebo to losartan 100 mg

Intervention Type DRUG

Placebo tablet to match losartan 100 mg, once daily

Placebo to losartan 50 mg

Intervention Type DRUG

Placebo tablet to match losartan 50 mg, once daily

Losartan

Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

Tablet containing losartan potassium (100 mg), once daily

Placebo to MK-0954A

Intervention Type DRUG

Placebo tablet to match MK-0954A, once daily

Placebo to losartan 50 mg

Intervention Type DRUG

Placebo tablet to match losartan 50 mg, once daily

Interventions

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MK-0954A

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

Intervention Type DRUG

Losartan

Tablet containing losartan potassium (100 mg), once daily

Intervention Type DRUG

Placebo to MK-0954A

Placebo tablet to match MK-0954A, once daily

Intervention Type DRUG

Placebo to losartan 100 mg

Placebo tablet to match losartan 100 mg, once daily

Intervention Type DRUG

Placebo to losartan 50 mg

Placebo tablet to match losartan 50 mg, once daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No