Clinical trial

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

Name

0954A-352

Description

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

Trial arms

Trial start

2011-03-29

Estimated PCD

2012-02-07

Trial end

2012-02-07

Status

Completed

Phase

Early phase I

Treatment

MK-0954A

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

Arms:

MK-0954A

Losartan

Tablet containing losartan potassium (100 mg), once daily

Arms:

Losartan

Placebo to MK-0954A

Placebo tablet to match MK-0954A, once daily

Arms:

Losartan

Placebo to losartan 100 mg

Placebo tablet to match losartan 100 mg, once daily

Arms:

MK-0954A

Placebo to losartan 50 mg

Placebo tablet to match losartan 50 mg, once daily

Arms:

Losartan, MK-0954A

Size

336

Primary endpoint

Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)

Baseline and Week 8

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

8 weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 336, 'type': 'ACTUAL'}}

Updated at

2024-05-17

1 organization

2 products

1 drug

1 indication

Organization

Product

Indication

Drug

Product