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

Chong Kun Dang

Status and phase: Not yet enrolling; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: sacubitril/valsartan(dose increasing); Drug: Valsartan; Drug: sacubitril/valsatran(dose maintenance)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06643819

A119_01HTN2312

Details and patient eligibility

About

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

Enrollment: 324 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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324 participants in 3 patient groups

Test Group1

Experimental group

Treatment:

Drug: sacubitril/valsatran(dose maintenance)

Test Group2

Experimental group

Treatment:

Drug: sacubitril/valsartan(dose increasing)

CONTROL

Active Comparator group

Treatment:

Drug: Valsartan