Hypertension
Conditions
Brief summary
A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HGP2304 in patients with essential hypertension
Interventions
DRUGHGP2304-1
Test drug
DRUGHGP2304-2
Test drug
DRUGRLD2209-1
Control drug
DRUGRLD2209-2
Control drug
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in 24 hours ambulatory systolic blood pressure | baseline, 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in nocturnal ambulatory pulse pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in sitting systolic blood pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in sitting diastolic blood 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 |
| Blood pressure response rate | baseline, 4 weeks, 10 weeks |
| Change from baseline in 24 hours ambulatory systolic blood pressure | baseline, 4 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 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 diurnal ambulatory pulse pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in nocturnal ambulatory diastolic blood pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in nocturnal ambulatory systolic blood pressure | baseline, 4 weeks, 10 weeks |
Countries
South Korea
Outcome results
None listed