Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Detailed Description
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This study is a Randomized, Double-blind, Multi-center, Therapeutic confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Official Title
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A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: D064 and D702, QD
* Drug: D064 and Placebo of D702, QD
* Drug: Placebo of D064 and D702, QD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are 19 years old or older. Subjects who are mean blood pressure measured in the arm selected as the reference arm meets the following criteria: Didn't take antihypertensive drug 140 mmHg ≤ MSSBP(mean sitting SBP) < 180 mmHg Taking antihypertensive drug 130 mmHg ≤ MSSBP(mean sitting SBP) < 180 mmHg Subjects who have voluntarily decided to participate in this clinical trial and signed ICF. Exclusion Criteria: Subjects with a history of secondary hypertension or suspected secondary hypertension Subjects with symptomatic orthostatic hypotension Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c > 9.0%) Subjects with Severe heart failure(NYHA Class 3,4) etc., Subjects with a history of unstable angina, moderate or malignant retinopathy, etc., within 6 months at the time of screening Subjects with a history of disability to investigational product ADME at the time of screening Subjects with abnormalities in laboratory test results at the time of screening Subjects with hypersensitivity or history of investigational product and similar drugs Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening Subjects who received other investigational product within 4 weeks of screening visit Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last investigational product Subjects who are unable to participate in this clinical trial at the discretion of the investigator

Ages Eligible for Study
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Minimum Age: 19 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: Experimental Group<br>D064 and D702 Combination Therapy | Drug: D064 and D702, QD<br>* Experimental Group Subjects assigned to this group are treated with D064, D702<br>* Other names: D064 and D702 Combination Therapy;|
| Active Comparator: Comparator Group 1<br>D064 Monotherapy | Drug: D064 and Placebo of D702, QD<br>* Comparator Group Subjects assigned to this group are treated with D064, placebo of D702<br>* Other names: D064 Monotherapy;|
| Active Comparator: Comparator Group 2<br>D702 Monotherapy | Drug: Placebo of D064 and D702, QD<br>* Comparator Group Subjects assigned to this group are treated with D702, placebo of D064<br>* Other names: D702 Monotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in MSSBP(mean sitting SBP) | Compare experimental group with comparator group | 8 weeks |