Clinical Efficacy and Safety Evaluation of HCP1904-1 in Essential Hypertension Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate of efficacy and safety of HCP1904-1 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.

Detailed Description
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A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients

Official Title
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A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: HCP1904-1
* Drug: RLD2001-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age Patients who understands the process of clinical study and voluntarily signs a peer letter Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions Blood pressure medication taken patients: 130mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg Blood pressure medication free patients: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg Visit2: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP <180mmHg, sit DBP < 110mmHg Exclusion Criteria: Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP Orthostatic hypotension with symptoms within 3months of 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 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 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 othe reason

Ages Eligible for Study
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Minimum Age: 18 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: HCP1904-1<br> | Drug: HCP1904-1<br>* Take it once daily for 8 weeks orally.<br>|
| Active Comparator: RLD2001-1<br> | Drug: RLD2001-1<br>* 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 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 4 | 
| Change from baseline in mean sitting diastolic blood pressure(mmHg) |  | Week 4,8 | 
| Change from baseline in mean pulse blood pressure(mmHg) |  | Week 4,8 | 
| Responder rate |  | Week 4, 8 | 
| target blood pressure reach rate |  | Week 4, 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Losartan, Chlorthalidone