RecruitingPhase 3NCT06416865

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


Sponsor

AJU Pharm Co., Ltd.

Enrollment

190 participants

Start Date

Jun 27, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new blood pressure medication called AJU-C52 in adults with essential hypertension (high blood pressure without a known secondary cause). The trial is evaluating how effective and safe the drug is at lowering blood pressure. **You may be eligible if...** - You are 19 years or older - You have been diagnosed with essential (primary) high blood pressure, or are already taking blood pressure medication - If you are not currently on medication, your top blood pressure number (systolic) is between 160–200 mmHg - If you are already on medication, your top blood pressure number is between 140–200 mmHg - Your bottom blood pressure number (diastolic) is below 110 mmHg - You are willing to give consent **You may NOT be eligible if...** - Your blood pressure readings vary too widely between measurements - You have secondary hypertension (high blood pressure caused by another condition) - You have significant heart or stroke history - You have had a malignant tumor (cancer) within the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

AJU Pharm Co., Ltd.

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06416865


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