A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).

Official Title
-----------------
A Phase III, Randomized, Active-comparator Controlled and a Long-term Clinical Trial to Study the Safety of MK-0954A (L100/H12.5 mg) in Japanese Patients With Essential Hypertension Uncontrolled With MK-954H (L50/H12.5 mg) [PREMINENT®]

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: MK-0954A
* Drug: MK-954H
* Drug: Placebo to MK-0954A
* Drug: Placebo to MK-954H


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Participant has a diagnosis of essential hypertension. Participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication. Participant has a mean trough SiDBP of >=90mmHg and < 110mmHg. Participant has a mean trough SiSBP of >=140mmHg and < 200mmHg. 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 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. Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MK-954H (L50/H12.5)<br>One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension) | Drug: MK-954H<br>* Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily<br>* Other names: Preminent®;Drug: Placebo to MK-0954A<br>* Placebo tablet to match MK-0954A, once daily<br>|
| Experimental: MK-0954A (L100/H12.5)<br>One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension | Drug: MK-0954A<br>* Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily<br>Drug: Placebo to MK-954H<br>* Placebo tablet to match MK-954H, once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension) |  | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8 | Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings. | Baseline and Week 8 (End of Double-blind Period) | 
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 | Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings. | Baseline and Week 8 (End of Double-blind Period) | 

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