Efficacy and Safety of AJU-C52 in Essential Hypertension Patients

NCT ID: NCT06416865

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2024-08-31

Brief Summary

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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

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AJU-C52L, AJU-C52

Treatment Period 1: AJU-C52L+C52R1L placebo

Treatment Period 2: AJU-C52+C52R1M placebo

Group Type EXPERIMENTAL

AJU-C52L, AJU-C52

Intervention Type 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

Treatment Period 1: C52R1L+AJU-C52L placebo

Treatment Period 2: C52R1M+AJU-C52 placebo

Group Type EXPERIMENTAL

C52R1L, C52R1M

Intervention Type 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.

Interventions

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AJU-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.

Intervention Type DRUG

C52R1L, 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AJU Pharm Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AJU Pharm Co., Ltd.

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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INAE PARK

Role: CONTACT

+82-02-2630-0700

Facility Contacts

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INAE PARK

Role: primary

+82-02-2630-0700

Other Identifiers

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21HT30601

Identifier Type: -

Identifier Source: org_study_id

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