Clinical Trial to Evaluate the Efficacy and the Safety of Antihypertensive Tablets

Study Overview
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Brief Summary
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The purpose of this study is to determine the optimal dosage of the clinical trial which is evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.

Detailed Description
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Evaluating the antihypertensive efficacy and the safety of OJP-2028 tablets in patients with the uncomplicated essential hypertension.

Official Title
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A 8-Week, Randomized, Double-blind, Parallel Designed, Phase II Multi-center Clinical Trial to Evaluate the Antihypertensive Efficacy and the Safety of OJP-2028 Tablets in Patients With the Uncomplicated Essential Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: OJP-2028


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women (Age 18-75 years) Uncomplicated essential hypertension: Clinic sitting SiDBP between 90 and 109 mmHg after 2 week placebo run-in period Exclusion Criteria: Secondary hypertension History and/or signs of cardiovascular complications (eg; myocardial infarction, unstable angina) Pregnancy or lactation Contraindications to the antihypertensive drugs to be used during the treatment period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>OJP-2028 1mg/day | Drug: OJP-2028<br>* Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo.day for 8 weeks. Reference group(Group 5): Reference Drug/day for 8 weeks.<br>|
| Experimental: Group 2<br>OJP-2028 2mg/day | Drug: OJP-2028<br>* Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo.day for 8 weeks. Reference group(Group 5): Reference Drug/day for 8 weeks.<br>|
| Experimental: Group 3<br>OJP-2028 4mg/day | Drug: OJP-2028<br>* Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo.day for 8 weeks. Reference group(Group 5): Reference Drug/day for 8 weeks.<br>|
| Placebo Comparator: Group 4<br>Placebo | Drug: OJP-2028<br>* Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo.day for 8 weeks. Reference group(Group 5): Reference Drug/day for 8 weeks.<br>|
| Other: Group 5<br>Reference drug | Drug: OJP-2028<br>* Experimental: 1mg/day, 2mg/day, 4mg/day for 8 weeks. Placebo Comparator: Placebo.day for 8 weeks. Reference group(Group 5): Reference Drug/day for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average SiDBP Differences of test group vs control group per each dosage by comparison with the baseline. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average SiSBP Differences of each group by comparison with the baseline. |  | 8 weeks | 
| Responder rate of each group by comparison with the baseline. |  | 8 weeks | 
| Average SiDBP and SiSBP Differences of each group by comparison with the baseline. |  | 8 weeks |