Clinical trial

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

Name

21HT30601

Description

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

Trial arms

Trial start

2022-06-27

Estimated PCD

2022-12-12

Trial end

2024-08-31

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

AJU-C52L, AJU-C52

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.

Arms:

C52R1L, C52R1M

Size

190

Primary endpoint

Changes in MSSBP(mean sitting systolic blood pressure)

8th week

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 190, 'type': 'ESTIMATED'}}

Updated at

2024-05-22

1 organization

2 products

1 indication

Organization

Product

Indication

Product