A Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension

Study Overview
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Brief Summary
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A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 in patients with essential hypertension

Official Title
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A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: HCP1803-3
* Drug: RLD2002
* Drug: HPP2003-3
* Drug: HPP2004


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions mean sitSBP <180 mmHg and mean sitDBP < 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1 Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2 Exclusion Criteria: Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1 Orthostatic hypotension with symptoms within 3 months prior to visit 1. Secondary hypertensive patient or suspected to be Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus Active gout or hyperuricemia (uric acid ≥ 9mg/dL) Severe heart disease or severe neurovascular disease Moderate or malignant retinopathy Clinically significant hematological finding Severe renal diseases (eGFR<30mL/min/1.73m2) Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range) Hypokalemia or Hyperkalemia(K<3.5mmol/L or K ≥ 5.5mmol/L) Hyponatremia or Hypernatremia(Na<135mmol/L or Na ≥ 155mmol/L) Hypercalcemia History of malignancy tumor History of autoimmune disease History of alcohol or drug abuse Positive to pregnancy test, nursing mother, intention on pregnancy Considered by investigator as not appropriate to participate in the clinical study with other reason

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<br>HCP1803-3 | Drug: HCP1803-3<br>* Take it once daily for 8 weeks orally.<br>Drug: HPP2004<br>* Placebo drug. Take it once daily for 8 weeks orally.<br>|
| Active Comparator: Active Comparator<br>RLD2002 | Drug: RLD2002<br>* Take it once daily for 8 weeks orally.<br>Drug: HPP2003-3<br>* Placebo drug. Take it once daily for 8 weeks orally.<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 |  | 4 weeks, 8 weeks | 
| Blood pressure response rate |  | 4 weeks, 8 weeks | 
| Treatment response rate |  | 4 weeks, 8 weeks | 
| Change from baseline in pulse pressure |  | baseline, 4 weeks, 8 weeks |