Efficacy and Safety of AJU-C52 in Essential Hypertension Patients

Phase 3

Recruiting

• Conditions: Essential Hypertension
• Interventions: Drug: AJU-C52L, AJU-C52; Drug: C52R1L, C52R1M

• Registration Number: NCT06416865
• Lead Sponsor: AJU Pharm Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-27
• Primary Completion: 2022-12-12
• Status Verified: 2024-05
• Study First Submitted: 2024-05-12
• Study First Submitted QC: 2024-05-12
• Study First Posted: 2024-05-16
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AJU-C52L, AJU-C52	AJU-C52L, AJU-C52	Treatment Period 1: AJU-C52L+C52R1L placebo Treatment Period 2: AJU-C52+C52R1M placebo
C52R1L, C52R1M	C52R1L, C52R1M	Treatment Period 1: C52R1L+AJU-C52L placebo Treatment Period 2: C52R1M+AJU-C52 placebo

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AJU Pharm Co., Ltd.; 🇰🇷 Seoul, Korea, Republic of