Hypertension
Conditions
Brief summary
A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension
Interventions
DRUGHCP1803
HCP1803
DRUGAmlodipine
Amlodipine
DRUGLosartan
Losartan
DRUGPlacebo
Placebo
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
* Patient with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and mean sitDBP \< 110 mmHg at Visit 1, Visit 2
Exclusion criteria
* Patient with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1 * Patient with difference of ≥ 15 mmHg in mean sitSBP between Visit 1 and Visit 2 * Patient with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg at Visit 1, Visit 2 * Patient with secondary hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in sitting systolic blood pressure | baseline, 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in sitting systolic blood pressure | baseline, 4 weeks | — |
| Change from baseline in sitting distolic blood pressure | baseline, 4 weeks, 8 weeks | — |
| Proportion of subjects achieving blood pressure control | 4 weeks, 8 weeks | sitSBP/sitDBP \< 140/90 mmHg |
| Proportion of responder | baseline, 4 weeks, 8 weeks | Change from baseline in sitSBP/sitDBP ≥ 20/10 mmHg |
| Change from baseline in pulse pressure(sitSBP - sitDBP) | baseline, 4 weeks, 8 weeks | — |
Countries
South Korea
Outcome results
None listed