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COMPLETEDPHASE3

MK-0954E Study in Participants With Hypertension (MK-0954E-357)

A Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodipine Co-administration

NCT01302691•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5) (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5 in Japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (L50+A5).

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant has a diagnosis of essential hypertension.
•Participant is being treated with single or dual treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
•Participant has a mean trough SiDBP of ≥ 90 mmHg and \< 110 mmHg.
•Participant has a mean trough SiSBP of ≥ 140 mmHg and \< 200 mmHg.
•Participant has no clinically significant abnormality at screening visit.

Exclusion Criteria

•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, amlodipine or dihydropyridine drug, 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 has had a recent history within the last year of drug or alcohol abuse or dependence.
•Participant is pregnant or breastfeeding, or expecting to conceive OR the pregnancy test is positive at screening visit (Visit 1).
•Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.

Key Dates

Start Date

January 1, 2011

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

March 15, 2019

Enrollment

327

ACTUAL participants

Conditions

Hypertension

Interventions

losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)

DRUG

Losartan potassium

DRUG

Amlodipine besylate

DRUG

Placebo to MK-0954E

DRUG

Placebo to losartan potassium

DRUG

Placebo to amlodipine besylate

DRUG

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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MK-0954E Study in Participants With Hypertension (MK-0954E-357)

Inclusion Criteria

Exclusion Criteria

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