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NCT06416865 Clinical Trial

Efficacy and Safety of AJU-C52 in Essential Hypertension Patients

Essential Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06416865
Other study ID # 21HT30601
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 27, 2022
Est. completion date August 31, 2024

Study information
Verified date May 2024
Source AJU Pharm Co., Ltd.
Contact INAE PARK
Phone +82-02-2630-0700
Email ajuf13001@ajupharm.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 190
Est. completion date August 31, 2024
Est. primary completion date December 12, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.
• 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.

Locations
Country Name City State
Korea, Republic of AJU Pharm Co., Ltd. Seoul

Sponsors (1)
Lead Sponsor Collaborator
AJU Pharm Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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