Evaluating AJU-C52 for treating essential hypertension
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
This study is testing a new treatment called AJU-C52 to see if it can help people with high blood pressure who aren't getting good results from their current medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | AJU Pharm Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06416865 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical trial is designed to assess the efficacy and safety of AJU-C52 in patients with essential hypertension who have not achieved adequate blood pressure control with the current treatment, C52R1L. The study employs a randomized, double-blind, multi-center approach to compare the effects of AJU-C52 against a combination treatment of C52R1M. Participants will be closely monitored for changes in blood pressure and any adverse effects throughout the trial period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 years or older diagnosed with essential hypertension who have not achieved adequate blood pressure control.
Not a fit: Patients with secondary hypertension, cardiovascular or cerebrovascular diseases, or a history of malignant tumors within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients struggling to control their essential hypertension.
How similar studies have performed: While this specific approach is novel, similar studies evaluating new antihypertensive treatments have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- AJU Pharm Co., Ltd. — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Inae Park
- Email: ajuf13001@ajupharm.co.kr
- Phone: +82-02-2630-0700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.