Efficacy and Safety of AJU-C52 in Essential Hypertension Patients

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06416865

Enrollment

190

Registered

2024-05-16

Start date

2022-06-27

Completion date

2024-08-31

Last updated

2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Brief 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

Interventions

DRUGAJU-C52L, AJU-C52

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.

DRUGC52R1L, C52R1M

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Contacts

Primary ContactINAE PARK

ajuf13001@ajupharm.co.kr+82-02-2630-0700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026