Hypertension
Conditions
Brief summary
A phase 3 study to evaluate efficacy and safety of HCP1401
Detailed description
A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605
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
* Hypertension patient who satisfied below condition at Visit 1. * patient who takes antihypertensive drug * 140mmHg \<= sitSBP \<= 200mmHg * patient who doesn't take antihypertensive drug * 160mmHg \<= sitSBP \<= 200mmHg * 140mmHg \<= sitSBP \<= 200mmHg at Visit 2
Exclusion criteria
* Patient who have received 4 or more antihypertensive drug * Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1 * Patient with sitDBP \>= 120mmHg at Visit 2 * Patient with secondary hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in sitting systolic blood pressure at week 8 | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in sitting diastolic blood pressure at week 2 and week 8 | 2 weeks and 8 weeks |
| Change from baseline in sitting systolic blood pressure at week 2 | 2 weeks |
| Proportion of subjects achieving Blood Pressure control | 2 weeks and 8 weeks |
Countries
South Korea
Outcome results
None listed