A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients

Study Overview
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Brief Summary
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A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate the Efficacy and Safety of HGP2102 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 HGP2102 in Patients With Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: HGP2102-1
* Drug: HGP2102-2
* Drug: RLD2209-1
* Drug: RLD2209-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions sitSBP<180 mmHg and sitDBP<110mg for patients receiving any BP-lowering drug within 1 month prior to Visit 1 140mmHG≤sitSBP<180mmHg and 60mmHg≤sitDBP<110mmHg Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions 24h-ABPM: 130mmHg≤ SBP <170mmHg clinic BP: 140 mmHg ≤ sitSBP < 180 mmHg and 60 mmHg ≤ sitDBP < 110 mmHg Exclusion Criteria: Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1 Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1 Orthostatic hypotension with symptoms within 3 months prior to visit 1 Secondary hypertension patient or suspected to be Uncontrolled type II diabetes mellitus (HbA1c > 9%) or type I diabetes mellitus Severe heart disease or severe neurovascular disease Moderate or malignant retinopathy Severe renal diseases (eGFR<30mL/min/1.73m2) Severe or active hepatopathy (AST or ALT ≥ 2 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) History of malignancy tumor 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: Experimental1<br>Take HGP2102-1 once daily for 4 weeks orally, and then take HGP2102-2 once daily for 6 weeks orally. | Drug: HGP2102-1<br>* Test drug<br>Drug: HGP2102-2<br>* Test drug<br>|
| Experimental: Experimental2<br>Take HGP2102-1 once daily for 10 weeks orally. | Drug: HGP2102-1<br>* Test drug<br>|
| Active Comparator: Active Comparator<br>Take RLD2209-1 once daily for 4 weeks orally, and then take RLD2209-2 once daily for 6 weeks orally. | Drug: RLD2209-1<br>* Control drug<br>Drug: RLD2209-2<br>* Control drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 24 hours ambulatory systolic blood pressure |  | baseline, 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 24 hours ambulatory systolic blood pressure |  | baseline, 4 weeks | 
| Change from baseline in 24 hours ambulatory diastolic blood pressure |  | baseline, 4 weeks, 10 weeks | 
| Change from baseline in 24 hours ambulatory pulse pressure |  | baseline, 4 weeks, 10 weeks | 
| Change from baseline in diurnal ambulatory systolic blood pressure |  | baseline, 4 weeks, 10 weeks | 
| Change from baseline in diurnal ambulatory diastolic blood pressure |  | baseline, 4 weeks, 10 weeks | 
| Change from baseline in diurnal ambulatory pulse pressure |  | baseline, 4 weeks, 10 weeks | 
| Change from baseline in nocturnal ambulatory systolic blood pressure |  | baseline, 4 weeks, 10 weeks | 
| Change from baseline in nocturnal ambulatory diastolic blood pressure |  | baseline, 4 weeks, 10 weeks | 
| Change from baseline in nocturnal ambulatory pulse pressure |  | baseline, 4 weeks, 10 weeks | 
| Change from baseline in sitting systolic blood pressure |  | baseline, 4 weeks, 10 weeks | 
| Change from baseline in sitting diastolic blood pressure |  | baseline, 4 weeks, 10 weeks | 
| Change from baseline in sitting pulse pressure |  | baseline, 4 weeks, 10 weeks | 
| Proportion of subjects achieving blood pressure control |  | baseline, 4 weeks, 10 weeks | 
| Blood pressure response rate |  | baseline, 4 weeks, 10 weeks |