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

Study Overview
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: MK-0954A
* Drug: Losartan
* Drug: Placebo to MK-0954A
* Drug: Placebo to losartan 100 mg
* Drug: Placebo to losartan 50 mg


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-0954A<br>Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks. | Drug: MK-0954A<br>* Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily<br>Drug: Placebo to losartan 100 mg<br>* Placebo tablet to match losartan 100 mg, once daily<br>Drug: Placebo to losartan 50 mg<br>* Placebo tablet to match losartan 50 mg, once daily<br>|
| Active Comparator: Losartan<br>Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks. | Drug: Losartan<br>* Tablet containing losartan potassium (100 mg), once daily<br>Drug: Placebo to MK-0954A<br>* Placebo tablet to match MK-0954A, once daily<br>Drug: Placebo to losartan 50 mg<br>* Placebo tablet to match losartan 50 mg, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and Week 8 | 
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essential hypertension, Uncontrolled hypertension, Antihypertensive agents, Blood pressure