Efficacy and Safety of AJU-C52 in Essential Hypertension Patients

NCT06416865 | Recruiting Phase 3

• 1 other identifier: 21HT30601
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in MSSBP(mean sitting systolic blood pressure)

  Changes in MSSBP(mean sitting systolic blood pressure) at the 8th week afeter administration of investigational products from the baseline.

  8th week

Study Arms (2)

AJU-C52L, AJU-C52

EXPERIMENTAL

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

Drug: AJU-C52L, AJU-C52

C52R1L, C52R1M

EXPERIMENTAL

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

Drug: C52R1L, C52R1M

Interventions

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.

AJU-C52L, AJU-C52

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.

C52R1L, C52R1M

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

AJU Pharm Co., Ltd.

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

INAE PARK

CONTACT

+82-02-2630-0700; ajuf13001@ajupharm.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: June 27, 2022
• Primary Completion: December 12, 2022
• Study Completion: August 31, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)