Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A
ConditionEssential Hypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorChong Kun Dang Pharmaceutical
About this trial
Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A(Sacubitril∙Valsartan)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants who are 19 years old or older.
Participants who have voluntarily decided to participate in this clinical trial and signed ICF.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Sacubitril∙Valsartan(dose maintenance)
DrugDuring 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)
DrugDuring 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
DrugDuring 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.
Treatment groups
324 Participants
are divided into 3 treatment groupsGroup A: Test Group1Experimental treatment 1 intervention
Group B: Test Group2Experimental treatment 1 intervention
Group C: CONTROLActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 baselineSponsors and contacts
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Source ClinicalTrials.gov