A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients

Study Overview
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Brief Summary
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A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension

Official Title
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A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: HCP2102-1
* Drug: HPP2104-1
* Drug: HCP2102-2
* Drug: HPP2104-2
* Drug: RLD2106-1
* Drug: HPP2103-1
* Drug: RLD2106-2
* Drug: HPP2103-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥ 19 years Patients who understands the process of clinical study and voluntarily signs a peer letter Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions Blood pressure medication taken patients: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg Blood pressure medication free patients: 160mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg Visit 2: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg Exclusion Criteria: Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP Orthostatic hypotension with symptoms within 3 months prior to visit 1 Secondary hypertension 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 Severe or malignant retinopathy Clinically significant hematological finding Severe renal diseases (eGFR<30mL/min/1.73m2) Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times) Hypokalemia or Hyperkalemia(K<3.5mmol/L or K ≥ 5.5mmol/L) Hyponatremia or Hypernatremia(Na<135mmol/L or Na ≥ 155mmol/L) Hypercalcemia(Ca ≥ 10.5mg/dL) 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>HCP2102 | Drug: HCP2102-1<br>* Take once daily for 2 weeks orally<br>Drug: HPP2104-1<br>* Placebo drug. Take once daily for 2 weeks orally<br>Drug: HCP2102-2<br>* Take once daily for 6 weeks orally<br>Drug: HPP2104-2<br>* Placebo drug. Take once daily for 6 weeks orally<br>|
| Active Comparator: Active Comparator<br>RLD2106 | Drug: RLD2106-1<br>* Take once daily for 2 weeks orally<br>Drug: HPP2103-1<br>* Placebo drug. Take once daily for 2 weeks orally<br>Drug: RLD2106-2<br>* Take once daily for 6 weeks orally<br>Drug: HPP2103-2<br>* Placebo drug. Take once daily for 6 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 mean sitting systolic blood pressure(mmHg) |  | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting systolic blood pressure(mmHg) |  | week 2 | 
| Change from baseline in mean sitting diastolic blood pressure(mmHg) |  | week 2, 8 | 
| Change from baseline in mean pulse blood pressure(mmHg) |  | week 2, 8 | 
| Target blood pressure reaching rate(%) |  | week 2, 8 | 
| Blood pressure responder rate(%) |  | week 2, 8 |