Hypertension
Conditions
Brief summary
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 in patients with essential hypertension
Interventions
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. Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions * mean sitSBP \<180 mmHg and mean sitDBP \< 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1 * 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1 2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg at Visit 2
Exclusion criteria
1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1 2. Orthostatic hypotension with symptoms within 3 months prior to visit 1. 3. Secondary hypertensive patient or suspected to be 4. Uncontrolled diabetes mellitus(HbA1c \> 9%) or type I diabetes mellitus 5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL) 6. Severe heart disease or severe neurovascular disease 7. Moderate or malignant retinopathy 8. Clinically significant hematological finding 9. Severe renal diseases (eGFR\<30mL/min/1.73m2) 10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range) 11. Hypokalemia or Hyperkalemia(K\<3.5mmol/L or K ≥ 5.5mmol/L) 12. Hyponatremia or Hypernatremia(Na\<135mmol/L or Na ≥ 155mmol/L) 13. Hypercalcemia 14. History of malignancy tumor 15. History of autoimmune disease 16. History of alcohol or drug abuse 17. Positive to pregnancy test, nursing mother, intention on pregnancy 18. 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 sitting systolic blood pressure | baseline, 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in sitting distolic blood pressure | baseline, 4 weeks, 8 weeks |
| Proportion of subjects achieving blood pressure control | 4 weeks, 8 weeks |
| Change from baseline in sitting systolic blood pressure | baseline, 4 weeks |
| Treatment response rate | 4 weeks, 8 weeks |
| Change from baseline in pulse pressure | baseline, 4 weeks, 8 weeks |
| Blood pressure response rate | 4 weeks, 8 weeks |
Countries
South Korea
Outcome results
None listed