NCT06416865
Recruiting
Phase 3
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
ConditionsEssential Hypertension
Overview
- Phase
- Phase 3
- Intervention
- AJU-C52L, AJU-C52
- Conditions
- Essential Hypertension
- Sponsor
- AJU Pharm Co., Ltd.
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Changes in MSSBP(mean sitting systolic blood pressure)
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
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
Arms & Interventions
AJU-C52L, AJU-C52
Treatment Period 1: AJU-C52L+C52R1L placebo Treatment Period 2: AJU-C52+C52R1M placebo
Intervention: AJU-C52L, AJU-C52
C52R1L, C52R1M
Treatment Period 1: C52R1L+AJU-C52L placebo Treatment Period 2: C52R1M+AJU-C52 placebo
Intervention: C52R1L, C52R1M
Outcomes
Primary Outcomes
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.
Study Sites (1)
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