Efficacy and Safety of AJU-C52 in Essential Hypertension Patients

NCT06416865 — Phase 3, Completed, 193 participants, AJU Pharm Co., Ltd.

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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

Registry	NCT06416865
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	193 (Actual)
Sponsor	AJU Pharm Co., Ltd. (Industry)
Conditions	Essential Hypertension
Interventions	AJU-C52L, AJU-C52, C52R1L, C52R1M (Drug)
Dates	start 2022-10-18, primary completion 2024-12-23, completion 2025-02-19, first posted 2024-05-16, last updated 2026-09-21
Locations	1 site in South Korea

-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

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+Arms and interventions

Arm	Type	Interventions	Description
AJU-C52L, AJU-C52	Experimental	Drug: AJU-C52L, AJU-C52	Treatment Period 1: AJU-C52L+C52R1L placebo Treatment Period 2: AJU-C52+C52R1M placebo
C52R1L, C52R1M	Experimental	Drug: C52R1L, C52R1M	Treatment Period 1: C52R1L+AJU-C52L placebo Treatment Period 2: C52R1M+AJU-C52 placebo

AJU-C52L, AJU-C52 (Drug): 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, C52R1M (Drug): 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.

+Outcome measures

Primary outcomes

Changes in MSSBP(mean sitting systolic blood pressure) [8th week]: Changes in MSSBP(mean sitting systolic blood pressure) at the 8th week afeter administration of investigational products from the baseline.

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
AJU Pharm Co., Ltd.	Seoul	South Korea

+Publications

Results publication: 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. PMID 42723352