Clinical trial NCT06174766: A Study to Evaluate Efficacy and Safety of HGP2102 in Essential Hypertension Patients
Official title: A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HGP2102 in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 324
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. 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
2. 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:

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

Primary outcomes:
measure: Change from baseline in 24 hours ambulatory systolic blood pressure
timeFrame: baseline, 10 weeks
Secondary outcomes:
measure: Change from baseline in 24 hours ambulatory systolic blood pressure
timeFrame: baseline, 4 weeks
measure: Change from baseline in 24 hours ambulatory diastolic blood pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change from baseline in 24 hours ambulatory pulse pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change from baseline in diurnal ambulatory systolic blood pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change from baseline in diurnal ambulatory diastolic blood pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change from baseline in diurnal ambulatory pulse pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change from baseline in nocturnal ambulatory systolic blood pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change from baseline in nocturnal ambulatory diastolic blood pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change from baseline in nocturnal ambulatory pulse pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change from baseline in sitting systolic blood pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change from baseline in sitting diastolic blood pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change from baseline in sitting pulse pressure
timeFrame: baseline, 4 weeks, 10 weeks
measure: Proportion of subjects achieving blood pressure control
timeFrame: baseline, 4 weeks, 10 weeks
measure: Blood pressure response rate
timeFrame: baseline, 4 weeks, 10 weeks
Other outcomes:
Locations:
city: Seodaemun-gu
country: Korea, Republic of
facility: Sevrance hosptal
state: Seoul
Study officials:
References: