A Study to Evaluate Efficacy and Safety of HGP2304 in Essential Hypertension Patients

August 27, 2026 updated by: Hanmi Pharmaceutical Company Limited

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HGP2304 in Patients With Essential Hypertension

A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HGP2304 in patients with essential hypertension

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
356

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Seok Min Kang, Ph.D

Study Locations

  • South Korea
    • Seoul
      • Seodaemun-gu, Seoul, South Korea, 03722
        • Severance hosptal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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

  2. 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:

  1. Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
  2. Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
  3. Orthostatic hypotension with symptoms within 3 months prior to visit 1
  4. Secondary hypertension patient or suspected to be
  5. Uncontrolled type II diabetes mellitus (HbA1c > 9%) or type I diabetes mellitus
  6. Severe heart disease or severe neurovascular disease
  7. Moderate or malignant retinopathy
  8. Severe renal diseases (eGFR<30mL/min/1.73m2)
  9. Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)
  10. Hypokalemia or Hyperkalemia (K<3.5mmol/L or K ≥ 5.5mmol/L)
  11. Hyponatremia or Hypernatremia (Na<135mmol/L or Na ≥ 155mmol/L)
  12. History of malignancy tumor
  13. History of alcohol or drug abuse
  14. Positive to pregnancy test, nursing mother, intention on pregnancy
  15. Considered by investigator as not appropriate to participate in the clinical study with other reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HGP2304-2
Take HGP2304-1 once daily for 4 weeks orally, and then take HGP2304-2 once daily for 6 weeks orally.
Drug: HGP2304-1
Test drug
Drug: HGP2304-2
Test drug
Experimental: HGP2304-1
Take HGP2304-1 once daily for 10 weeks orally.
Drug: HGP2304-1
Test drug
Active Comparator: RLD2209-2
Take RLD2209-1 once daily for 4 weeks orally, and then take RLD2209-2 once daily for 6 weeks orally.
Drug: RLD2209-1
Control drug
Drug: RLD2209-2
Control drug

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in 24 hours ambulatory systolic blood pressure
Time Frame: baseline, 10 weeks
baseline, 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in 24 hours ambulatory systolic blood pressure
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change from baseline in 24 hours ambulatory diastolic blood pressure
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Change from baseline in diurnal ambulatory systolic blood pressure
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Change from baseline in diurnal ambulatory diastolic blood pressure
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Change from baseline in diurnal ambulatory pulse pressure
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory systolic blood pressure
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory diastolic blood pressure
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory pulse pressure
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Change from baseline in sitting systolic blood pressure
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Change from baseline in sitting diastolic blood pressure
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Change from baseline in sitting pulse pressure
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Proportion of subjects achieving blood pressure control
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Blood pressure response rate
Time Frame: baseline, 4 weeks, 10 weeks
baseline, 4 weeks, 10 weeks
Change from baseline in 24 hours ambulatory pulse pressure
Time Frame: Baseline, 4 weeks, 10 weeks
Baseline, 4 weeks, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM-ENCORE-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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