A Study to Determine the Effectiveness and Tolerability of MK8141 in Patients With High Blood Pressure (MK-8141-006)

Study Overview
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Brief Summary
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This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood pressure in patients who have hypertension (high blood pressure).

Official Title
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A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Assess the Efficacy and Tolerability of MK8141 in Hypertensive Patients

Conditions
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Hypertension

Intervention / Treatment
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* Drug: MK8141
* Drug: Comparator: placebo (unspecified)
* Drug: Enalapril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You are 35 to 65 years of age In the past 14 days you have not been treated for hypertension In the past 14 days you have not taken more than 2 medications to treat high blood pressure You are a woman who is not able to have children or do not use birth control Exclusion Criteria: You are taking more than 2 medications to treat high blood pressure You have a history of a stroke, transient ischemic attack (TIA), heart attack, congestive heart failure, coronary artery bypass surgery You have Type 1 or 2 diabetes mellitus You have an active liver disease, gallbladder disease, or bowel disease You are HIV positive You have certain types of cancer You abuse drug or alcohol You have participated in another clinical study in last 4 weeks

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 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: 1<br>Arm 1: Drug 250 mg | Drug: MK8141<br>* MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period<br>|
| Experimental: 2<br>Arm 2: Drug 500 mg | Drug: MK8141<br>* MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period<br>|
| Active Comparator: 3<br>Arm 3: Active Comparator | Drug: Enalapril<br>* Enalapril 20 mg tablet once daily. 4 week treatment period.<br>* Other names: Vasotec®;|
| Placebo Comparator: 4<br>Arm 4: Pbo Comparator | Drug: Comparator: placebo (unspecified)<br>* MK8141 Pbo tablet once daily. 4 week treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment. |  | after 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare MK8141 versus placebo in lowering 24-hour mean sitting blood pressure by ambulatory blood pressure monitoring and in lowering trough mean sitting diastolic and systolic blood pressure after 4 weeks of treatment. |  | after 4 weeks of treatment |