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Clinical Efficacy and Safety Evaluation of HCP1904-2 in Essential Hypertension Patients

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HCP1904-2
RLD2001-2
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Losartan, Chlorthalidone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients over 18 years of age
  2. Patients who understands the process of clinical study and voluntarily signs a peer letter

  3. 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
  4. 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

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HCP1904-2

RLD2001-2

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in mean sitting systolic blood pressure(mmHg)

Secondary Outcome Measures

Change from baseline in mean sitting systolic blood pressure(mmHg)
Change from baseline in mean sitting diastolic blood pressure(mmHg)
Change from baseline in mean pulse blood pressure(mmHg)
Responder rate
target blood pressure reach rate

Full Information

First Posted
March 31, 2021
Last Updated
September 20, 2023
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04830449
Brief Title
Clinical Efficacy and Safety Evaluation of HCP1904-2 in Essential Hypertension Patients
Official Title
A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-2 in Essential Hypertension Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 29, 2020 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate of efficacy and safety of HCP1904-2 and RLD2001-2 alone in patients with essential hypertension inadequately controlled on RLD2001-2 monotherapy.
Detailed Description
A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-2 in Essential Hypertension Patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Losartan, Chlorthalidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCP1904-2
Arm Type
Experimental
Arm Title
RLD2001-2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HCP1904-2
Intervention Description
Take it once daily for 8 weeks orally.
Intervention Type
Drug
Intervention Name(s)
RLD2001-2
Intervention Description
Take it once daily for 8 weeks orally.
Primary Outcome Measure Information:
Title
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame
Week 4
Title
Change from baseline in mean sitting diastolic blood pressure(mmHg)
Time Frame
Week 4,8
Title
Change from baseline in mean pulse blood pressure(mmHg)
Time Frame
Week 4,8
Title
Responder rate
Time Frame
Week 4, 8
Title
target blood pressure reach rate
Time Frame
Week 4, 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

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Clinical Efficacy and Safety Evaluation of HCP1904-2 in Essential Hypertension Patients

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