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

Phase 3RecruitingNCT06643819

Chong Kun Dang Pharmaceutical324 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

324

Conditions

Essential Hypertension

Interventions

Sacubitril∙Valsartan(dose maintenance)DRUG

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)DRUG

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 10 weeks after baseline

Central Contacts

Keehyun Ham, Project Leader

CONTACT

+82-2-2194-0479 hamki@ckdpharm.com

Data from ClinicalTrials.gov

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