Efficacy and Safety of AJU-C52 in Essential Hypertension Patients

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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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AJU Pharm Co., Ltd.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

AJU Pharm Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2025
First posted: May 16, 2024
Registry last updated: Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed