CKD-202A (sacubitril/valsartan) for adults with high blood pressure
A Randomized, Double-blind, Active-controlled, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A
This trial will test whether CKD-202A (sacubitril/valsartan) controls blood pressure safely in adults with essential hypertension compared with valsartan.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chong Kun Dang Pharmaceutical Industry-sponsored |
| Locations | 1 site (Wŏnju) |
| Trial ID | NCT06643819 on ClinicalTrials.gov |
What this trial studies
This phase 3 interventional trial will enroll adults with essential hypertension to receive either CKD-202A (sacubitril/valsartan) using a maintenance or an increasing dose regimen, or valsartan. Participants will attend regular clinic visits for blood pressure measurements, safety labs, and monitoring of adverse events during the treatment period. The main goals are to compare blood pressure lowering and the safety profile of sacubitril/valsartan regimens versus valsartan. Key exclusions include secondary hypertension, orthostatic hypotension, poorly controlled diabetes, recent investigational drug use, substance abuse, and pregnancy or lactation.
Who should consider this trial
Good fit: Adults aged 19 years or older with diagnosed essential hypertension who can provide informed consent and meet the study health criteria are appropriate candidates.
Not a fit: Patients with secondary or suspected secondary hypertension, orthostatic hypotension, poorly controlled diabetes, recent participation in other drug trials, active substance abuse, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, CKD-202A could offer better blood pressure control or improved tolerability compared with standard valsartan therapy.
How similar studies have performed: Previous trials of sacubitril/valsartan have shown larger blood pressure reductions than valsartan in some hypertensive populations, so this approach builds on earlier positive findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants who are 19 years old or older. * Participants who have voluntarily decided to participate in this clinical trial and signed ICF. Exclusion Criteria: * Participants with a history of secondary hypertension or suspected secondary hypertension. * Participants with a orthostatic hypotension. * Participants who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period. * Participants with type 1 diabetes or poorly controlled diabetes. * Participants who treated other clinical trial drugs within 4 weeks of screening visit. * Participants with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening * Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug * Participants who are unable to participate in this clinical trial at the discretion of the investigator.
Where this trial is running
Wŏnju
- Wonju Severance Christian Hospital — Wŏnju, South Korea (Recruiting)
Study contacts
- Study coordinator: Keehyun Ham, Project Leader
- Email: hamki@ckdpharm.com
- Phone: +82-2-2194-0479
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.