Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A
NCT ID: NCT06643819
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
324 participants
INTERVENTIONAL
2024-10-14
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test Group1
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 Period, During the 6 weeks out of 10 weeks of Treatment Period(Double blind), All TEST1 pariticipants are treateed 1 CKD-202A (Sacubitril∙Valsartan) 100 mg, 1 placebo of CKD-202A(Sacubitril∙Valsartan) 200mg, 1 placebo of D764(Valsartan 160 mg) each, and a total of 3 oral doses once a day.
Test Group2
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 Period, During the 6 weeks out of 10 weeks of Treatment Period(Double blind), All TEST1 pariticipants are treateed 1 placebo of CKD-202A (Sacubitril∙Valsartan) 100 mg, 1 CKD-202A(Sacubitril∙Valsartan) 200mg, 1 placebo of D764(Valsartan 160 mg) each, and a total of 3 oral doses once a day.
CONTROL
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 Period, During the 6 weeks out of 10 weeks of Treatment Period(Double blind), All TEST1 pariticipants are treateed 1 placebo of CKD-202A (Sacubitril∙Valsartan) 100 mg, 1 placebo of CKD-202A(Sacubitril∙Valsartan) 200mg, 1 D764(Valsartan 160 mg) each, and a total of 3 oral doses once a day.
Interventions
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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 Period, During the 6 weeks out of 10 weeks of Treatment Period(Double blind), All TEST1 pariticipants are treateed 1 CKD-202A (Sacubitril∙Valsartan) 100 mg, 1 placebo of CKD-202A(Sacubitril∙Valsartan) 200mg, 1 placebo of D764(Valsartan 160 mg) each, and a total of 3 oral doses once a day.
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 Period, During the 6 weeks out of 10 weeks of Treatment Period(Double blind), All TEST1 pariticipants are treateed 1 placebo of CKD-202A (Sacubitril∙Valsartan) 100 mg, 1 CKD-202A(Sacubitril∙Valsartan) 200mg, 1 placebo of D764(Valsartan 160 mg) each, and a total of 3 oral doses once a day.
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 Period, During the 6 weeks out of 10 weeks of Treatment Period(Double blind), All TEST1 pariticipants are treateed 1 placebo of CKD-202A (Sacubitril∙Valsartan) 100 mg, 1 placebo of CKD-202A(Sacubitril∙Valsartan) 200mg, 1 D764(Valsartan 160 mg) each, and a total of 3 oral doses once a day.
Eligibility Criteria
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Inclusion Criteria
* Participants who have voluntarily decided to participate in this clinical trial and signed ICF.
Exclusion Criteria
* 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.
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A119_01HTN2312
Identifier Type: -
Identifier Source: org_study_id
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