Efficacy and Safety of AJU-C52 in Essential Hypertension Patients

Aju Pharm

Status and phase: Enrolling; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: AJU-C52L, AJU-C52; Drug: C52R1L, C52R1M

Study type: Interventional

Funder types: Industry

Identifiers

NCT06416865

21HT30601

Details and patient eligibility

About

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

Enrollment: 190 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups

AJU-C52L, AJU-C52

Experimental group

Description:

Treatment Period 1: AJU-C52L+C52R1L placebo Treatment Period 2: AJU-C52+C52R1M placebo

Treatment:

Drug: AJU-C52L, AJU-C52

C52R1L, C52R1M

Experimental group

Description:

Treatment Period 1: C52R1L+AJU-C52L placebo Treatment Period 2: C52R1M+AJU-C52 placebo

Treatment:

Drug: C52R1L, C52R1M