HypertensionPhase 3HM_APOLLONCT05362110
A Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension
A Phase 3 study testing HCP1803-3, RLD2002 and HPP2003-3 in people with Hypertension, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 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?
- HCP1803-3, RLD2002 and HPP2003-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 May 2022to 5 Jun 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 with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions
- mean sitSBP <180 mmHg and mean sitDBP < 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
- 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
- Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2
Who cannot join
- Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
- Orthostatic hypotension with symptoms within 3 months prior to 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
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- Moderate or malignant retinopathy
- Clinically significant hematological finding
- Severe renal diseases (eGFR<30mL/min/1.73m2)
- Severe or active hepatopathy (AST or ALT ≥ 3 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)
- 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 other reason
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326
About this study
Official title: A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 in patients with essential hypertension
- Conditions
- Hypertension
- Being tested
- HCP1803-3, RLD2002, HPP2003-3, HPP2004
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1803-3Drug
Take it once daily for 8 weeks orally.
RLD2002Drug
Take it once daily for 8 weeks orally.
HPP2003-3Drug
Placebo drug. Take it once daily for 8 weeks orally.
HPP2004Drug
Placebo drug. Take it once daily for 8 weeks orally.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | HCP1803-3 Receives: Drug: HCP1803-3; Drug: HPP2004 |
| Active Comparator | Active comparator | RLD2002 Receives: Drug: RLD2002; Drug: HPP2003-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sitting systolic blood pressure
Measured: baseline, 8 weeks
Secondary outcomes (6)
Change from baseline in sitting systolic blood pressure
Measured: baseline, 4 weeks
Change from baseline in sitting distolic blood pressure
Measured: baseline, 4 weeks, 8 weeks
Proportion of subjects achieving blood pressure control
Measured: 4 weeks, 8 weeks
Blood pressure response rate
Measured: 4 weeks, 8 weeks
Treatment response rate
Measured: 4 weeks, 8 weeks
Change from baseline in pulse pressure
Measured: baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start16 May 2022
- Primary completion5 Jun 2023
- Study completion5 Jun 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
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moo-Yong Rhee, M.D., Ph.D., Principal investigator, Donggguk University Ilsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362110
- Sponsor's protocol ID
- HM-APOLLO-301
- Acronym
- HM_APOLLO
- Status last verified
- Sep 2023
- First submitted
- 1 May 2022
- Last updated
- 26 Sep 2023
- Results posted
- 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 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HCP1803 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT05362110
- Acronym / sponsor ID
- HM_APOLLO / HM-APOLLO-301
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 5 May 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 3 study to evaluate efficacy and safety of HCP1803 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: HCP1803-3, Drug: HPP2004HCP1803-3 |
| Active Comparator | Active comparator | Drug: RLD2002, Drug: HPP2003-3RLD2002 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions
- Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and 60 mmHg ≤ mean sitDBP < 110 mmHg at Visit 2
Key exclusion criteria (18 listed)
- Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
- Orthostatic hypotension with symptoms within 3 months prior to 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)
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 |
|---|---|---|
| HCP1803-3Take it once daily for 8 weeks orally. | Drug | Experimental |
| RLD2002Take it once daily for 8 weeks orally. | Drug | Active Comparator |
| HPP2003-3Placebo drug. Take it once daily for 8 weeks orally. | Drug | Active Comparator |
| HPP2004Placebo drug. Take it once daily for 8 weeks orally. | Drug | Experimental |
Primary outcome
Change from baseline in sitting systolic blood pressure
Time frame: baseline, 8 weeks
6 secondary outcomes
Change from baseline in sitting systolic blood pressure
Time frame: baseline, 4 weeks
Change from baseline in sitting distolic blood pressure
Time frame: baseline, 4 weeks, 8 weeks
Proportion of subjects achieving blood pressure control
Time frame: 4 weeks, 8 weeks
Blood pressure response rate
Time frame: 4 weeks, 8 weeks
Treatment response rate
Time frame: 4 weeks, 8 weeks
Change from baseline in pulse pressure
Time frame: baseline, 4 weeks, 8 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 26 Sep 2023.
- 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.
Moo-Yong Rhee, M.D., Ph.D. principal investigator
Donggguk University Ilsan Hospital
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 HCP1803-3, RLD2002 and HPP2003-3 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 4 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 26 Sep 2023. 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 sitting systolic blood pressure (time frame: baseline, 8 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 26 Sep 2023.