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

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

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

Study Overview

• Status: Recruiting
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: Valsartan; Drug: Sacubitril∙Valsartan(dose maintenance); Drug: Sacubitril∙Valsartan(dose increasing)

• Study Type: Interventional
• Enrollment (Estimated): 324
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Keehyun Ham, Project Leader; Phone Number: +82-2-2194-0479; Email: hamki@ckdpharm.com

Study Locations

• South Korea
  • Wŏnju, South Korea
    • Recruiting
    • Wonju Severance Christian Hospital
    • Contact: Byungsu Yoo, PI; Phone Number: +82-33-741-0917; Email: yubs@yonsei.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group1	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 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.
Experimental: Test Group2	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 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.
Active Comparator: CONTROL	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in MASBP(Mean Ambulatory Systolic Blood Pressure)	The purpose of Clinical Trial is confirmation that test group 2 (Sacubitril∙Valsartan 200mg) is superior to control group (Valsartan 160mg)	10 weeks after baseline

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Essential Hypertension; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Amino Acids; Amino Acids, Essential; Tetrazoles; Valine; Amino Acids, Branched-Chain; Valsartan
• Other Study ID Numbers: A119_01HTN2312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No