A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

Study Overview
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Brief Summary
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A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension

Official Title
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A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: HCP1803
* Drug: Amlodipine
* Drug: Losartan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg at Visit 1, Visit 2 Exclusion Criteria: Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1 Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2 Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2 Patient with secondary hypertension

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 1<br>HCP1803 High | Drug: HCP1803<br>* HCP1803<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Experimental 2<br>HCP1803 Middle | Drug: HCP1803<br>* HCP1803<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: Experimental 3<br>HCP1803 Low | Drug: HCP1803<br>* HCP1803<br>Drug: Placebo<br>* Placebo<br>|
| Active Comparator: Active Comparator 1<br>HGP0904 High | Drug: Amlodipine<br>* Amlodipine<br>|
| Active Comparator: Active Comparator 2<br>HGP0904 Low | Drug: Amlodipine<br>* Amlodipine<br>Drug: Placebo<br>* Placebo<br>|
| Active Comparator: Active Comparator 3<br>HGP0608 | Drug: Losartan<br>* Losartan<br>Drug: Placebo<br>* Placebo<br>|
| Placebo Comparator: Placebo Comparator<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting systolic blood pressure |  | baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting systolic blood pressure |  | baseline, 4 weeks | 
| Change from baseline in sitting distolic blood pressure |  | baseline, 4 weeks, 8 weeks | 
| Proportion of subjects achieving blood pressure control | sitSBP/sitDBP < 140/90 mmHg | 4 weeks, 8 weeks | 
| Proportion of responder | Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg | baseline, 4 weeks, 8 weeks | 
| Change from baseline in pulse pressure(sitSBP - sitDBP) |  | baseline, 4 weeks, 8 weeks |