Hypertension
Conditions
Brief summary
A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension
Interventions
DRUGHCP2102-1
Take once daily for 2 weeks orally
DRUGHPP2104-1
Placebo drug. Take once daily for 2 weeks orally
DRUGHCP2102-2
Take once daily for 6 weeks orally
DRUGHPP2104-2
Placebo drug. Take once daily for 6 weeks orally
DRUGRLD2106-1
Take once daily for 2 weeks orally
DRUGHPP2103-1
Placebo drug. Take once daily for 2 weeks orally
DRUGRLD2106-2
Take once daily for 6 weeks orally
DRUGHPP2103-2
Placebo drug. Take once daily for 6 weeks orally
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 aged ≥ 19 years 2. Patients who understands the process of clinical study and voluntarily signs a peer letter 3. Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions * Blood pressure medication taken patients: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg * Blood pressure medication free patients: 160mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg 4. Visit 2: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg
Exclusion criteria
1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP 2. Orthostatic hypotension with symptoms within 3 months prior to visit 1 3. Secondary hypertension 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. Severe or malignant retinopathy 8. Clinically significant hematological finding 9. Severe renal diseases (eGFR\<30mL/min/1.73m2) 10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times) 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(Ca ≥ 10.5mg/dL) 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 mean sitting systolic blood pressure(mmHg) | week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean sitting systolic blood pressure(mmHg) | week 2 |
| Change from baseline in mean sitting diastolic blood pressure(mmHg) | week 2, 8 |
| Change from baseline in mean pulse blood pressure(mmHg) | week 2, 8 |
| Target blood pressure reaching rate(%) | week 2, 8 |
| Blood pressure responder rate(%) | week 2, 8 |
Countries
South Korea
Outcome results
None listed