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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Placebo to losartan 100 mg; Drug: Placebo to MK-0954A; Drug: Losartan; Drug: MK-0954A; Drug: Placebo to losartan 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01307046

0954A-352

Details and patient eligibility

About

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

Enrollment: 336 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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336 participants in 2 patient groups

MK-0954A

Experimental group

Description:

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

Treatment:

Drug: MK-0954A

Drug: Placebo to losartan 50 mg

Drug: Placebo to losartan 100 mg

Losartan

Active Comparator group

Description:

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

Treatment:

Drug: Losartan

Drug: Placebo to MK-0954A

Drug: Placebo to losartan 50 mg