A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
- Registration Number
- NCT02916602
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 340
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment HCP1401 HCP1401 Reference HCP0605 HCP0605
- Primary Outcome Measures
Name Time Method Change from baseline in sitting systolic blood pressure at week 8 8 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi-Do, Korea, Republic of