A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients

Phase 3

Not yet recruiting

Interventions: Drug: HGP2102-1
Drug: RLD2209-1
Drug: HGP2102-2
Drug: RLD2209-2

Brief Summary: A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate the Efficacy and Safety of HGP2102 in patients with Essential Hypertension

Recruitment & Eligibility

Inclusion Criteria

Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions
- sitSBP<180 mmHg and sitDBP<110mg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
- 140mmHG≤sitSBP<180mmHg and 60mmHg≤sitDBP<110mmHg
Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions
- 24h-ABPM: 130mmHg≤ SBP <170mmHg
- clinic BP: 140 mmHg ≤ sitSBP < 180 mmHg and 60 mmHg ≤ sitDBP < 110 mmHg

Exclusion Criteria

Difference between arms greater than 20 mmHg for mean sitSBP or 10mmHg for mean sitDBP at Visit 1
Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1
Orthostatic hypotension with symptoms within 3 months prior to visit 1
Secondary hypertension patient or suspected to be
Uncontrolled type II diabetes mellitus (HbA1c > 9%) or type I diabetes mellitus
Severe heart disease or severe neurovascular disease
Moderate or malignant retinopathy
Severe renal diseases (eGFR<30mL/min/1.73m2)
Severe or active hepatopathy (AST or ALT ≥ 2 times of normal range)
Hypokalemia or Hyperkalemia (K<3.5mmol/L or K ≥ 5.5mmol/L)
Hyponatremia or Hypernatremia (Na<135mmol/L or Na ≥ 155mmol/L)
History of malignancy tumor
History of alcohol or drug abuse
Positive to pregnancy test, nursing mother, intention on pregnancy
Considered by investigator as not appropriate to participate in the clinical study with other reason

Arm && Interventions

Group	Intervention	Description
Experimental1	HGP2102-1	Take HGP2102-1 once daily for 4 weeks orally, and then take HGP2102-2 once daily for 6 weeks orally.
Experimental1	HGP2102-2	Take HGP2102-1 once daily for 4 weeks orally, and then take HGP2102-2 once daily for 6 weeks orally.
Experimental2	HGP2102-1	Take HGP2102-1 once daily for 10 weeks orally.
Active Comparator	RLD2209-1	Take RLD2209-1 once daily for 4 weeks orally, and then take RLD2209-2 once daily for 6 weeks orally.
Active Comparator	RLD2209-2	Take RLD2209-1 once daily for 4 weeks orally, and then take RLD2209-2 once daily for 6 weeks orally.

Primary Outcome Measures

Name	Time	Method
Change from baseline in 24 hours ambulatory systolic blood pressure	baseline, 10 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in diurnal ambulatory pulse pressure	baseline, 4 weeks, 10 weeks
Change from baseline in 24 hours ambulatory diastolic blood pressure	baseline, 4 weeks, 10 weeks
Change from baseline in 24 hours ambulatory pulse pressure	baseline, 4 weeks, 10 weeks
Change from baseline in sitting pulse pressure	baseline, 4 weeks, 10 weeks
Proportion of subjects achieving blood pressure control	baseline, 4 weeks, 10 weeks
Change from baseline in 24 hours ambulatory systolic blood pressure	baseline, 4 weeks
Change from baseline in diurnal ambulatory systolic blood pressure	baseline, 4 weeks, 10 weeks
Change from baseline in diurnal ambulatory diastolic blood pressure	baseline, 4 weeks, 10 weeks
Change from baseline in sitting diastolic blood pressure	baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory systolic blood pressure	baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory pulse pressure	baseline, 4 weeks, 10 weeks
Blood pressure response rate	baseline, 4 weeks, 10 weeks
Change from baseline in nocturnal ambulatory diastolic blood pressure	baseline, 4 weeks, 10 weeks
Change from baseline in sitting systolic blood pressure	baseline, 4 weeks, 10 weeks