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Recruiting NCT06643819

Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A

Phase III Interventional Essential Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sacubitril∙Valsartan(dose maintenance), Sacubitril∙Valsartan(dose increasing), Valsartan.
Who it may be relevant to
Registry conditions: Essential Hypertension. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Active-controlled, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A

Overview

Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A(Sacubitril∙Valsartan)

Interventions

  • Drug Sacubitril∙Valsartan(dose maintenance)
    During the 4 weeks of Placebo Run-in Period(Single blind), all participants are treated 1 placebo of CKD-202A(Sacubitril∙Valsartan) 100mg and 1 placebo of D763(Valsartan 80 mg) each, total of 2 oral doses once a day. After Placebo Run-in Period, During the 4 weeks out of 10 weeks of Treatment Period(Double blind), All TEST1 pariticipants are treated 1 CKD-202A (Sacubitril∙Valsartan) 100 mg and 1 placebo of D763(Valsartan 80 mg) each, total of 2 oral doses once a day. After 4 weeks of Treatment
  • Drug Sacubitril∙Valsartan(dose increasing)
    During the 4 weeks of Placebo Run-in Period(Single blind), all participants are treated 1 placebo of CKD-202A(Sacubitril∙Valsartan) 100mg and 1 placebo of D763(Valsartan 80 mg) each, total of 2 oral doses once a day. After Placebo Run-in Period, During the 4 weeks out of 10 weeks of Treatment Period(Double blind), All TEST2 pariticipants are treated 1 CKD-202A (Sacubitril∙Valsartan) 100 mg and 1 placebo of D763(Valsartan 80 mg) each, total of 2 oral doses once a day. After 4 weeks of Treatment
  • Drug Valsartan
    During the 4 weeks of Placebo Run-in Period(Single blind), all participants are treated 1 placebo of CKD-202A(Sacubitril∙Valsartan) 100mg and 1 placebo of D763(Valsartan 80 mg) each, total of 2 oral doses once a day. After Placebo Run-in Period, During the 4 weeks out of 10 weeks of Treatment Period(Double blind), All TEST2 pariticipants are treated 1 placebo of CKD-202A (Sacubitril∙Valsartan) 100 mg and 1 D763(Valsartan 80 mg) each, total of 2 oral doses once a day. After 4 weeks of Treatment P

Primary outcome measures

  • change from baseline in MASBP(Mean Ambulatory Systolic Blood Pressure) [Time frame: 10 weeks after baseline]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Wonju Severance Christian Hospital — Wŏnju

Identifiers

NCT: NCT06643819 · A119_01HTN2312

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗