CKD-202A (sacubitril/valsartan) for adults with high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.