- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06416865
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: INAE PARK
- Phone Number: +82-02-2630-0700
- Email: ajuf13001@ajupharm.co.kr
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- AJU Pharm Co., Ltd.
-
Contact:
- INAE PARK
- Phone Number: +82-02-2630-0700
- Email: ajuf13001@ajupharm.co.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AJU-C52L, AJU-C52
Treatment Period 1: AJU-C52L+C52R1L placebo Treatment Period 2: AJU-C52+C52R1M placebo |
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. |
Experimental: C52R1L, C52R1M
Treatment Period 1: C52R1L+AJU-C52L placebo Treatment Period 2: C52R1M+AJU-C52 placebo |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in MSSBP(mean sitting systolic blood pressure)
Time Frame: 8th week
|
Changes in MSSBP(mean sitting systolic blood pressure) at the 8th week afeter administration of investigational products from the baseline.
|
8th week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21HT30601
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Essential Hypertension
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Addpharma Inc.Completed
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
BayerCompletedHypertension, EssentialGermany
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
Addpharma Inc.Not yet recruitingHypertension,Essential
-
Instituto de Cardiologia do Rio Grande do SulRecruitingHypertension | Hypertension,EssentialBrazil
-
Federal University of Health Science of Porto AlegreIrmandade Santa Casa de Misericórdia de Porto Alegre; Leonhardt Ventures LLCNot yet recruitingHypertension | Hypertension,Essential
Clinical Trials on AJU-C52L, AJU-C52
-
AJU Pharm Co., Ltd.CompletedType2 DiabetesKorea, Republic of
-
AJU Pharm Co., Ltd.GL Pharm Tech CorporationCompleted
-
AJU Pharm Co., Ltd.GL Pharm Tech CorporationRecruiting
-
AJU Pharm Co., Ltd.RecruitingHypertensionKorea, Republic of
-
AJU Pharm Co., Ltd.CompletedDiabetes Mellitus, Type 2Korea, Republic of
-
AJU Pharm Co., Ltd.RecruitingHypertensionKorea, Republic of