Hypertension Clinical Trial
— HM_APOLLOOfficial title:
A Muticenter, Randomized, Double-blind, Parallel, Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
Verified date | July 2022 |
Source | Hanmi Pharmaceutical Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A multicenter, randomized, double-blind, parallel, phase 2 study to assess dose-response relationship of HCP1803 in patients with essential hypertension
Status | Completed |
Enrollment | 248 |
Est. completion date | February 26, 2020 |
Est. primary completion date | February 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Donggguk University Ilsan Hospital | Goyang-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Hanmi Pharmaceutical Company Limited |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in sitting systolic blood pressure | baseline, 8 weeks | ||
Secondary | Change from baseline in sitting systolic blood pressure | baseline, 4 weeks | ||
Secondary | Change from baseline in sitting distolic blood pressure | baseline, 4 weeks, 8 weeks | ||
Secondary | Proportion of subjects achieving blood pressure control | sitSBP/sitDBP < 140/90 mmHg | 4 weeks, 8 weeks | |
Secondary | Proportion of responder | Change from baseline in sitSBP/sitDBP = 20/10 mmHg | baseline, 4 weeks, 8 weeks | |
Secondary | Change from baseline in pulse pressure(sitSBP - sitDBP) | baseline, 4 weeks, 8 weeks |
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