Essential HypertensionPhase 3NCT06416865
Efficacy and Safety of AJU-C52 in Essential Hypertension Patients
A Phase 3 study testing AJU-C52L, AJU-C52 and C52R1L, C52R1M in people with Essential Hypertension, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial summary
A Randomized, Double-blind, Multi-center, Phase III study to evaluate the efficacy and safety of the AJU-C52 compared with the combination of C52R1M in patients with essential Hypertension Patients who have inappropriately controlled on C52R1L treament Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- AJU-C52L, AJU-C52 and C52R1L, C52R1M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Oct 2022to 19 Feb 2025
- 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
- Adults aged ≤19 years.
- Those who voluntarily signed the informed consent to participate in this study.
- A patient diagnosed with essential hypertension or Patients taking hypertension medication
- Those who are eligible for adequate blood pressure criteria during screening tests: Naïve patient-160 mmHg≤MSSBP<200 mmHg and MSDBP<110 mmHg/Patients taking hypertension medication-140 mmHg≤MSSBP<200 mmHg and MSDBP<110 mmHg
Who cannot join
- At the screening visit (Visit 1), patients had 3 blood pressure measurements in the arm with the higher average MSSBP, those whose maximum and minimum blood pressure differences are MSSBP 20 mmHg and MSDBP 10 mmHg
- Secondary hypertension patients or those with a history of suspected secondary hypertension
- Cardiovascular/cerebrovascular disease
- Those with a history of malignant tumor within 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase III Trial to Evaluate the Efficacy and Safety of AJU-C52 in Compared With C52R1M for Essential Hypertension Patients in Inappropriately Controlled on C52R1L Treatment
A Randomized, Double-blind, Multi-center, Phase III study to evaluate the efficacy and safety of the AJU-C52 compared with the combination of C52R1M in patients with essential Hypertension Patients who have inappropriately controlled on C52R1L treament
- Conditions
- Essential Hypertension
- Being tested
- AJU-C52L, AJU-C52, C52R1L, C52R1M
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJU-C52L, AJU-C52Drug
AJU-C52L+C52R1L placebo: Subjects take the investigational products once a day for 2 weeks.
AJU-C52+C52R1M placebo: Subjects take the investigational products once a day for 6 weeks.
C52R1L, C52R1MDrug
C52R1L+AJU-C52L placebo: Subjects take the investigational products once a day for 2 weeks.
C52R1M+AJU-C52 placebo: Subjects take the investigational products once a day for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AJU-C52L, AJU-C52 | Experimental | Treatment Period 1: AJU-C52L+C52R1L placebo
Treatment Period 2: AJU-C52+C52R1M placebo Receives: Drug: AJU-C52L, AJU-C52 |
| C52R1L, C52R1M | Experimental | Treatment Period 1: C52R1L+AJU-C52L placebo
Treatment Period 2: C52R1M+AJU-C52 placebo Receives: Drug: C52R1L, C52R1M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in MSSBP(mean sitting systolic blood pressure)
Changes in MSSBP(mean sitting systolic blood pressure) at the 8th week afeter administration of investigational products from the baseline.
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start18 Oct 2022
- Primary completion23 Dec 2024
- Study completion19 Feb 2025
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 Essential 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- AJU Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416865
- Sponsor's protocol ID
- 21HT30601
- Status last verified
- Sep 2026
- First submitted
- 12 May 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho IJ, Hong SJ, Kong MG, Jo SH, Cho EJ, Choi CU, Choi JH, Kim DH, Kim JH, Ihm SH, Pyun WB. Efficacy and Safety of a Single-Pill Triple Combination of Valsartan, Amlodipine, and Chlorthalidone in Patients With Essential Hypertension Inadequately Controlled on Dual Therapy With Valsartan and Amlodipine: A Randomized, Double-Blind, Multicenter, Phase 3 Trial. J Clin Hypertens (Greenwich). 2026 Sep;28(9):e70362. doi: 10.1111/jch.70362.
PubMed 42723352
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase III Trial to Evaluate the Efficacy and Safety of AJU-C52 in Compared With C52R1M for Essential Hypertension Patients in Inappropriately Controlled on C52R1L Treatment
- ClinicalTrials.gov ID
- NCT06416865
- Acronym / sponsor ID
- 21HT30601
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 16 May 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 Randomized, Double-blind, Multi-center, Phase III study to evaluate the efficacy and safety of the AJU-C52 compared with the combination of C52R1M in patients with essential Hypertension Patients who have inappropriately controlled on C52R1L treament
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AJU-C52L, AJU-C52 | Experimental | Drug: AJU-C52L, AJU-C52Treatment Period 1: AJU-C52L+C52R1L placebo Treatment Period 2: AJU-C52+C52R1M placebo |
| C52R1L, C52R1M | Experimental | Drug: C52R1L, C52R1MTreatment Period 1: C52R1L+AJU-C52L placebo Treatment Period 2: C52R1M+AJU-C52 placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≤19 years.
- Those who voluntarily signed the informed consent to participate in this study.
- A patient diagnosed with essential hypertension or Patients taking hypertension medication
- Those who are eligible for adequate blood pressure criteria during screening tests: Naïve patient-160 mmHg≤MSSBP<200 mmHg and MSDBP<110 mmHg/Patients taking hypertension medication-140 mmHg≤MSSBP<200 mmHg and MSDBP<110 mmHg
Key exclusion criteria (4 listed)
- At the screening visit (Visit 1), patients had 3 blood pressure measurements in the arm with the higher average MSSBP, those whose maximum and minimum blood pressure differences are MSSBP 20 mmHg and MSDBP 10 mmHg
- Secondary hypertension patients or those with a history of suspected secondary hypertension
- Cardiovascular/cerebrovascular disease
- Those with a history of malignant tumor within 5 years
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 |
|---|---|---|
| AJU-C52L, AJU-C52AJU-C52L+C52R1L placebo: Subjects take the investigational products once a day for 2 weeks. AJU-C52+C52R1M placebo: Subjects take the investigational products once a day for 6 weeks. | Drug | AJU-C52L, AJU-C52 |
| C52R1L, C52R1MC52R1L+AJU-C52L placebo: Subjects take the investigational products once a day for 2 weeks. C52R1M+AJU-C52 placebo: Subjects take the investigational products once a day for 6 weeks. | Drug | C52R1L, C52R1M |
Primary outcome
Changes in MSSBP(mean sitting systolic blood pressure)
Time frame: 8th week
Changes in MSSBP(mean sitting systolic blood pressure) at the 8th week afeter administration of investigational products from the baseline.
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 21 Sep 2026.
- Derived from this study: PubMed 42723352Cho IJ, Hong SJ, Kong MG, Jo SH, Cho EJ, Choi CU, Choi JH, Kim DH, Kim JH, Ihm SH, Pyun WB. Efficacy and Safety of a Single-Pill Triple Combination of Valsartan, Amlodipine, and Chlorthalidone in Patients With Essential Hypertension Inadequately Controlled on Dual Therapy With Valsartan and Amlodipine: A Randomized, Double-Blind, Multicenter, Phase 3 Trial. J Clin Hypertens (Greenwich). 2026 Sep;28(9):e70362. doi: 10.1111/jch.70362.
- 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 AJU-C52L, AJU-C52 and C52R1L, C52R1M in people with Essential Hypertension, run by AJU Pharm Co., Ltd. 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 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 21 Sep 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?
Changes in MSSBP(mean sitting systolic blood pressure) (time frame: 8th week). 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 NCT06416865, 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 21 Sep 2026.