HypertensionPhase 3NCT06174766
A Study to Evaluate Efficacy and Safety of HGP2304 in Essential Hypertension Patients
A Phase 3 study testing HGP2304-1, HGP2304-2 and RLD2209-1 in people with Hypertension, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HGP2304 in patients with essential hypertension Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- HGP2304-1, HGP2304-2 and RLD2209-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2024to 8 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Hypertension
- Being tested
- HGP2304-1, HGP2304-2, RLD2209-1, RLD2209-2
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGP2304-1Drug
Test drug
HGP2304-2Drug
Test drug
RLD2209-1Drug
Control drug
RLD2209-2Drug
Control drug
| Study group | Role | What they receive |
|---|---|---|
| HGP2304-2 | Experimental | Take HGP2304-1 once daily for 4 weeks orally, and then take HGP2304-2 once daily for 6 weeks orally. Receives: Drug: HGP2304-1; Drug: HGP2304-2 |
| HGP2304-1 | Experimental | Take HGP2304-1 once daily for 10 weeks orally. Receives: Drug: HGP2304-1 |
| RLD2209-2 | Active comparator | Take RLD2209-1 once daily for 4 weeks orally, and then take RLD2209-2 once daily for 6 weeks orally. Receives: Drug: RLD2209-1; Drug: RLD2209-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 24 hours ambulatory systolic blood pressure
Measured: baseline, 10 weeks
Secondary outcomes (14)
Change from baseline in 24 hours ambulatory systolic blood pressure
Measured: baseline, 4 weeks
Change from baseline in 24 hours ambulatory diastolic blood pressure
Measured: baseline, 4 weeks, 10 weeks
Change from baseline in 24 hours ambulatory pulse pressure
Measured: Baseline, 4 weeks, 10 weeks
Change from baseline in diurnal ambulatory systolic blood pressure
Measured: baseline, 4 weeks, 10 weeks
Change from baseline in diurnal ambulatory diastolic blood pressure
Measured: baseline, 4 weeks, 10 weeks
Change from baseline in diurnal ambulatory pulse pressure
Measured: baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory systolic blood pressure
Measured: baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory diastolic blood pressure
Measured: baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory pulse pressure
Measured: baseline, 4 weeks, 10 weeks
Change from baseline in sitting systolic blood pressure
Measured: baseline, 4 weeks, 10 weeks
Change from baseline in sitting diastolic blood pressure
Measured: baseline, 4 weeks, 10 weeks
Change from baseline in sitting pulse pressure
Measured: baseline, 4 weeks, 10 weeks
Proportion of subjects achieving blood pressure control
Measured: baseline, 4 weeks, 10 weeks
Blood pressure response rate
Measured: baseline, 4 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start10 May 2024
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174766
- Sponsor's protocol ID
- HM-ENCORE-301
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HGP2304 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT06174766
- Acronym / sponsor ID
- HM-ENCORE-301
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 May 2024 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HGP2304 in patients with essential hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HGP2304-2 | Experimental | Drug: HGP2304-1, Drug: HGP2304-2Take HGP2304-1 once daily for 4 weeks orally, and then take HGP2304-2 once daily for 6 weeks orally. |
| HGP2304-1 | Experimental | Drug: HGP2304-1Take HGP2304-1 once daily for 10 weeks orally. |
| RLD2209-2 | Active comparator | Drug: RLD2209-1, Drug: RLD2209-2Take RLD2209-1 once daily for 4 weeks orally, and then take RLD2209-2 once daily for 6 weeks orally. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions
- Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HGP2304-1Test drug | Drug | HGP2304-1, HGP2304-2 |
| HGP2304-2Test drug | Drug | HGP2304-2 |
| RLD2209-1Control drug | Drug | RLD2209-2 |
| RLD2209-2Control drug | Drug | RLD2209-2 |
Primary outcome
Change from baseline in 24 hours ambulatory systolic blood pressure
Time frame: baseline, 10 weeks
14 secondary outcomes
Change from baseline in 24 hours ambulatory systolic blood pressure
Time frame: baseline, 4 weeks
Change from baseline in 24 hours ambulatory diastolic blood pressure
Time frame: baseline, 4 weeks, 10 weeks
Change from baseline in 24 hours ambulatory pulse pressure
Time frame: Baseline, 4 weeks, 10 weeks
Change from baseline in diurnal ambulatory systolic blood pressure
Time frame: baseline, 4 weeks, 10 weeks
Change from baseline in diurnal ambulatory diastolic blood pressure
Time frame: baseline, 4 weeks, 10 weeks
Change from baseline in diurnal ambulatory pulse pressure
Time frame: baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory systolic blood pressure
Time frame: baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory diastolic blood pressure
Time frame: baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory pulse pressure
Time frame: baseline, 4 weeks, 10 weeks
Change from baseline in sitting systolic blood pressure
Time frame: baseline, 4 weeks, 10 weeks
Change from baseline in sitting diastolic blood pressure
Time frame: baseline, 4 weeks, 10 weeks
Change from baseline in sitting pulse pressure
Time frame: baseline, 4 weeks, 10 weeks
Proportion of subjects achieving blood pressure control
Time frame: baseline, 4 weeks, 10 weeks
Blood pressure response rate
Time frame: baseline, 4 weeks, 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HGP2304-1, HGP2304-2 and RLD2209-1 in people with Hypertension, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 24 hours ambulatory systolic blood pressure (time frame: baseline, 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.