HypertensionPhase 3HODO-2224NCT06646354
To Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia
A Phase 3 study testing Ezetimibe/Rosuvastatin/Candesartan/Amlodipine, Candesartan/Amlodipine and Candesartan/Rosuvastatin/Ezetimibe in people with Hypertension and Primary Hypercholesterolaemia, run by Hyundai Pharm at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase 3 trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Primary Hypercholesterolaemia
- What is being tested?
- Ezetimibe/Rosuvastatin/Candesartan/Amlodipine, Candesartan/Amlodipine and Candesartan/Rosuvastatin/Ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Apr 2025to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 19
- Patients with Essential Hypertension and Primary Hypercholesterolemia
Who cannot join
- Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
- Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase 3 trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia
Read the detailed description
This trial is a phase 3 study to evaluate the efficacy and safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia.
This is multi-center, double-blind, Active-controlled, parallel-group, phase 3 study.
- Conditions
- Hypertension, Primary Hypercholesterolaemia
- Being tested
- Ezetimibe/Rosuvastatin/Candesartan/Amlodipine, Candesartan/Amlodipine, Candesartan/Rosuvastatin/Ezetimibe
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe/Rosuvastatin/Candesartan/AmlodipineDrug
PO, QD, 8 weeks
Candesartan/AmlodipineDrug
PO, QD, 8 weeks
Candesartan/Rosuvastatin/EzetimibeDrug
PO, QD, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| HODO-2224-1+HODO-2224-2+HODO-2224-4 | Experimental | Oral tablet, QD Receives: Drug: Ezetimibe/Rosuvastatin/Candesartan/Amlodipine |
| HODO-2224-1+HODO-2224-4+HODO-2224-5 | Active comparator | Oral tablet, QD Receives: Drug: Candesartan/Amlodipine |
| HODO-2224-2+HODO-2224-3+HODO-2224-6 | Active comparator | Oral tablet, QD Receives: Drug: Candesartan/Rosuvastatin/Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density lipoprotein cholesterol (LDL-C)
LDL-C change at Week 8 compared HODO-2224-1 + HODO-2224-4 + HODO-2224-5 with HODO-2224
Measured: baseline and week 8
Mean sitting systolic blood pressure (MSSBP)
MSSBP change at week 8 compared HODO-2224-2 + HODO-2224-3 + HODO-2224-6 with HODO-2224
Measured: baseline and week 8
Secondary outcomes (1)
change of other Lipid profile
change of other Lipid profile
Measured: 0, 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start22 Apr 2025
- Primary completion19 May 2025
- Study completion31 Dec 2028 (estimated)
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.
- 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646354
- Sponsor's protocol ID
- HD_CARE_002
- Acronym
- HODO-2224
- Status last verified
- May 2025
- First submitted
- 15 Oct 2024
- Last updated
- 22 May 2025
- 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT06646354
- Acronym / sponsor ID
- HODO-2224 / HD_CARE_002
- Conditions
- Hypertension, Primary Hypercholesterolaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Hyundai PharmIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Oct 2024 (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, Active-controlled, Parallel group, Phase 3 trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia
Detailed description
This trial is a phase 3 study to evaluate the efficacy and safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia.
This is multi-center, double-blind, Active-controlled, parallel-group, phase 3 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HODO-2224-1+HODO-2224-2+HODO-2224-4 | Experimental | Drug: Ezetimibe/Rosuvastatin/Candesartan/AmlodipineOral tablet, QD |
| HODO-2224-1+HODO-2224-4+HODO-2224-5 | Active comparator | Drug: Candesartan/AmlodipineOral tablet, QD |
| HODO-2224-2+HODO-2224-3+HODO-2224-6 | Active comparator | Drug: Candesartan/Rosuvastatin/EzetimibeOral tablet, QD |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 19
- Patients with Essential Hypertension and Primary Hypercholesterolemia
Key exclusion criteria (2 listed)
- Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
- Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
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 |
|---|---|---|
| Ezetimibe/Rosuvastatin/Candesartan/AmlodipinePO, QD, 8 weeks | Drug | HODO-2224-1+HODO-2224-2+HODO-2224-4 |
| Candesartan/AmlodipinePO, QD, 8 weeks | Drug | HODO-2224-1+HODO-2224-4+HODO-2224-5 |
| Candesartan/Rosuvastatin/EzetimibePO, QD, 8 weeks | Drug | HODO-2224-2+HODO-2224-3+HODO-2224-6 |
Primary outcome
Low density lipoprotein cholesterol (LDL-C)
Time frame: baseline and week 8
LDL-C change at Week 8 compared HODO-2224-1 + HODO-2224-4 + HODO-2224-5 with HODO-2224
Mean sitting systolic blood pressure (MSSBP)
Time frame: baseline and week 8
MSSBP change at week 8 compared HODO-2224-2 + HODO-2224-3 + HODO-2224-6 with HODO-2224
1 secondary outcome
change of other Lipid profile
Time frame: 0, 4, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- 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.
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 Ezetimibe/Rosuvastatin/Candesartan/Amlodipine, Candesartan/Amlodipine and Candesartan/Rosuvastatin/Ezetimibe in people with Hypertension and Primary Hypercholesterolaemia, run by Hyundai Pharm 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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 22 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Low density lipoprotein cholesterol (LDL-C) (time frame: baseline and week 8). The study lists 2 primary outcomes in all. 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 22 May 2025.