Evaluating a new combination therapy for patients with high blood pressure
A Multi-center, Randomized, Double-blind, Parallel Design, Phase III Study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients with Essential Hypertension Inadequately Controlled with DWC202405
PHASE3 · Daewoong Pharmaceutical Co. LTD. · NCT06671392
This study is testing a new combination treatment for people with high blood pressure who aren't getting enough control from their current medication.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06671392 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical trial is designed to assess the efficacy and safety of a combination therapy involving DWC202405/DWC202313 and DWC202314 in patients with essential hypertension who are inadequately controlled with DWC202405. The study employs a multi-center, randomized, double-blind, parallel design to ensure robust results. Participants will be monitored for changes in their blood pressure levels and any potential side effects from the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with essential hypertension whose blood pressure is not adequately controlled with current medications.
Not a fit: Patients with severely elevated blood pressure or significant discrepancies in blood pressure readings between arms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients struggling to manage their hypertension.
How similar studies have performed: Other studies have shown promise in using combination therapies for hypertension, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Average systolic blood pressure (MSSBP) and average diastolic blood pressure (MSDBP) measured at the time of screening meet the following criteria (a) If antihypertensive drugs are being administered: 140 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg However, the criteria of 130 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg are applied to patients with the following diseases. Exclusion Criteria: * If the blood pressure measured at the time of screening and randomization is MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg * Those whose blood pressure differences measured on both arms at the time of screening are MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg
Where this trial is running
Seoul
- Korea University ANAM Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Jeon
- Email: sgcho@daewoong.co.kr
- Phone: 82-02-2228-8523
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.
Conditions: Essential Hypertension