HypertensionPhase 3NCT05450601
A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients
A Phase 3 study testing HCP2102-1, HPP2104-1 and HCP2102-2 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 the efficacy and safety of HCP2102 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?
- HCP2102-1, HPP2104-1 and HCP2102-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2022to 11 Dec 2023
- 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
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension
A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension
- Conditions
- Hypertension
- Being tested
- HCP2102-1, HPP2104-1, HCP2102-2, HPP2104-2, RLD2106-1
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP2102-1Drug
Take once daily for 2 weeks orally
HPP2104-1Drug
Placebo drug. Take once daily for 2 weeks orally
HCP2102-2Drug
Take once daily for 6 weeks orally
HPP2104-2Drug
Placebo drug. Take once daily for 6 weeks orally
RLD2106-1Drug
Take once daily for 2 weeks orally
HPP2103-1Drug
Placebo drug. Take once daily for 2 weeks orally
RLD2106-2Drug
Take once daily for 6 weeks orally
HPP2103-2Drug
Placebo drug. Take once daily for 6 weeks orally
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | HCP2102 Receives: Drug: HCP2102-1; Drug: HPP2104-1; Drug: HCP2102-2; Drug: HPP2104-2 |
| Active Comparator | Active comparator | RLD2106 Receives: Drug: RLD2106-1; Drug: HPP2103-1; Drug: RLD2106-2; Drug: HPP2103-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean sitting systolic blood pressure(mmHg)
Measured: week 8
Secondary outcomes (5)
Change from baseline in mean sitting systolic blood pressure(mmHg)
Measured: week 2
Change from baseline in mean sitting diastolic blood pressure(mmHg)
Measured: week 2, 8
Change from baseline in mean pulse blood pressure(mmHg)
Measured: week 2, 8
Target blood pressure reaching rate(%)
Measured: week 2, 8
Blood pressure responder rate(%)
Measured: week 2, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Sep 2022
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
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
- 249 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
- NCT05450601
- Sponsor's protocol ID
- HM-ALCH-302
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT05450601
- Acronym / sponsor ID
- HM-ALCH-302
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 11 Jul 2022 (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 the efficacy and safety of HCP2102 in patients with essential hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: HCP2102-1, Drug: HPP2104-1, Drug: HCP2102-2, Drug: HPP2104-2HCP2102 |
| Active Comparator | Active comparator | Drug: RLD2106-1, Drug: HPP2103-1, Drug: RLD2106-2, Drug: HPP2103-2RLD2106 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Visit 2: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
Key exclusion criteria (18 listed)
- 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)
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 |
|---|---|---|
| HCP2102-1Take once daily for 2 weeks orally | Drug | Experimental |
| HPP2104-1Placebo drug. Take once daily for 2 weeks orally | Drug | Experimental |
| HCP2102-2Take once daily for 6 weeks orally | Drug | Experimental |
| HPP2104-2Placebo drug. Take once daily for 6 weeks orally | Drug | Experimental |
| RLD2106-1Take once daily for 2 weeks orally | Drug | Active Comparator |
| HPP2103-1Placebo drug. Take once daily for 2 weeks orally | Drug | Active Comparator |
| RLD2106-2Take once daily for 6 weeks orally | Drug | Active Comparator |
| HPP2103-2Placebo drug. Take once daily for 6 weeks orally | Drug | Active Comparator |
Primary outcome
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time frame: week 8
5 secondary outcomes
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time frame: week 2
Change from baseline in mean sitting diastolic blood pressure(mmHg)
Time frame: week 2, 8
Change from baseline in mean pulse blood pressure(mmHg)
Time frame: week 2, 8
Target blood pressure reaching rate(%)
Time frame: week 2, 8
Blood pressure responder rate(%)
Time frame: week 2, 8
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 5 Mar 2024.
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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 HCP2102-1, HPP2104-1 and HCP2102-2 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 18 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 5 Mar 2024. 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 mean sitting systolic blood pressure(mmHg) (time frame: week 8). 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 5 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.