HypertensionPhase 2HM_APOLLONCT03897868
A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
A Phase 2 study testing HCP1803, Amlodipine and Losartan in people with Hypertension, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship 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, Amlodipine and Losartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Mar 2019to 26 Feb 2020
- Phase
- Phase 2
- 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
- Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg at Visit 1, Visit 2
Who cannot join
- Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
- Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2
- Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2
- Patient with secondary hypertension
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 Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension
- Conditions
- Hypertension
- Being tested
- HCP1803, Amlodipine, Losartan, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1803Drug
HCP1803
AmlodipineDrug
Amlodipine
LosartanDrug
Losartan
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | HCP1803 High Receives: Drug: HCP1803; Drug: Placebo |
| Experimental 2 | Experimental | HCP1803 Middle Receives: Drug: HCP1803; Drug: Placebo |
| Experimental 3 | Experimental | HCP1803 Low Receives: Drug: HCP1803; Drug: Placebo |
| Active Comparator 1 | Active comparator | HGP0904 High Receives: Drug: Amlodipine |
| Active Comparator 2 | Active comparator | HGP0904 Low Receives: Drug: Amlodipine; Drug: Placebo |
| Active Comparator 3 | Active comparator | HGP0608 Receives: Drug: Losartan; Drug: Placebo |
| Placebo Comparator | Placebo comparator | Placebo Receives: Drug: Placebo |
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 (5)
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
sitSBP/sitDBP < 140/90 mmHg
Measured: 4 weeks, 8 weeks
Proportion of responder
Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg
Measured: baseline, 4 weeks, 8 weeks
Change from baseline in pulse pressure(sitSBP - sitDBP)
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 posted1 Apr 2019
- Study start21 Mar 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 248 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
- NCT03897868
- Sponsor's protocol ID
- HM-APOLLO-201
- Acronym
- HM_APOLLO
- Status last verified
- Jul 2022
- First submitted
- 29 Mar 2019
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong SJ, Sung KC, Lim SW, Kim SY, Kim W, Shin J, Park S, Kim HY, Rhee MY; HM_APOLLO Investigators. Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study. Drug Des Devel Ther. 2020 Dec 31;14:5735-5746. doi: 10.2147/DDDT.S286586. eCollection 2020.
PubMed 33408462
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT03897868
- Acronym / sponsor ID
- HM_APOLLO / HM-APOLLO-201
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 1 Apr 2019 (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, parallel, phase 2 study to assess dose-response relationship 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
- 7
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: HCP1803, Drug: PlaceboHCP1803 High |
| Experimental 2 | Experimental | Drug: HCP1803, Drug: PlaceboHCP1803 Middle |
| Experimental 3 | Experimental | Drug: HCP1803, Drug: PlaceboHCP1803 Low |
| Active Comparator 1 | Active comparator | Drug: AmlodipineHGP0904 High |
| Active Comparator 2 | Active comparator | Drug: Amlodipine, Drug: PlaceboHGP0904 Low |
| Active Comparator 3 | Active comparator | Drug: Losartan, Drug: PlaceboHGP0608 |
| Placebo Comparator | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP < 180 mmHg and mean sitDBP < 110 mmHg at Visit 1, Visit 2
Key exclusion criteria (4 listed)
- Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
- Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2
- Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2
- Patient with secondary hypertension
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 |
|---|---|---|
| HCP1803HCP1803 | Drug | Experimental 1, Experimental 2, Experimental 3 |
| AmlodipineAmlodipine | Drug | Active Comparator 1, Active Comparator 2 |
| LosartanLosartan | Drug | Active Comparator 3 |
| PlaceboPlacebo | Drug | Active Comparator 2, Active Comparator 3, Experimental 1, Experimental 2, Experimental 3, Placebo Comparator |
Primary outcome
Change from baseline in sitting systolic blood pressure
Time frame: baseline, 8 weeks
5 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
Proportion of responder
Time frame: baseline, 4 weeks, 8 weeks
Change from baseline in pulse pressure(sitSBP - sitDBP)
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 14 Jul 2022.
- Derived from this study: PubMed 33408462Hong SJ, Sung KC, Lim SW, Kim SY, Kim W, Shin J, Park S, Kim HY, Rhee MY; HM_APOLLO Investigators. Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study. Drug Des Devel Ther. 2020 Dec 31;14:5735-5746. doi: 10.2147/DDDT.S286586. eCollection 2020.
- 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 2 study testing HCP1803, Amlodipine and Losartan 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 1 inclusion and 4 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 14 Jul 2022. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
On the ClinicalTrials.gov record for NCT03897868, which also lists 1 linked publication.
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 14 Jul 2022.