Hypertension
Conditions
Brief summary
A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension
Detailed description
A multicenter, randomized, double-blind, phase III study to evaluate efficacy and safety of HCP1803-4 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. 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 hypertensive patient or suspected to be 5. Clinically significant hematological finding 6. Severe heart disease or severe neurovascular disease 7. Moderate or malignant retinopathy 8. Uncontrolled diabetes mellitus or type I diabetes mellitus 9. Active gout or hyperuricemia 10. Severe renal diseases 11. Severe or active hepatopathy 12. Hypokalemia or Hyperkalemia 13. Hyponatremia or Hypernatremia 14. Hypercalcemia 15. History of malignancy tumor 16. History of autoimmune disease 17. History of alcohol or drug abuse 18. Positive to pregnancy test, nursing mother, intention on pregnancy 19. 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, 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in sitting systolic blood pressure | Baseline, 2 weeks, 6 weeks |
| Change from baseline in sitting diastolic blood pressure | Baseline, 2 weeks, 6 weeks, 10 weeks |
| Proportion of subjects achieving blood pressure control (sitSBP) | 2 weeks, 6 weeks, 10 weeks |
| Proportion of subjects achieving blood pressure control (sitSBP, sitDBP) | 2 weeks, 6 weeks, 10 weeks |
| Blood pressure response rate (sitSBP) | 2 weeks, 6 weeks, 10 weeks |
| Blood pressure response rate (sitSBP, sitDBP) | 2 weeks, 6 weeks, 10 weeks |
| Treatment response rate | 2 weeks, 6 weeks, 10 weeks |
| Change from baseline in pulse pressure | Baseline, 2 weeks, 6 weeks, 10 weeks |
Countries
South Korea
Contacts
CONTACTJee Won Shon
PRINCIPAL_INVESTIGATORMoo-Yong Rhee, M.D., Ph.D.
Donggguk University Ilsan Hospital
Outcome results
None listed