A Phase 2 Study to Assess Dose-response Relationship of HCP1803 in Patients With Essential Hypertension
NCT ID: NCT03897868
Last Updated: 2022-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
248 participants
INTERVENTIONAL
2019-03-21
2020-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental 1
HCP1803 High
HCP1803
HCP1803
Placebo
Placebo
Experimental 2
HCP1803 Middle
HCP1803
HCP1803
Placebo
Placebo
Experimental 3
HCP1803 Low
HCP1803
HCP1803
Placebo
Placebo
Active Comparator 1
HGP0904 High
Amlodipine
Amlodipine
Active Comparator 2
HGP0904 Low
Amlodipine
Amlodipine
Placebo
Placebo
Active Comparator 3
HGP0608
Losartan
Losartan
Placebo
Placebo
Placebo Comparator
Placebo
Placebo
Placebo
Interventions
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HCP1803
HCP1803
Amlodipine
Amlodipine
Losartan
Losartan
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Moo-Yong Rhee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Donggguk University Ilsan Hospital
Locations
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Donggguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Countries
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References
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Hong SJ, Sung KC, Lim SW, Kim SY, Kim W, Shin J, Park S, Kim HY, Rhee MY; HM_APOLLO Investigators. Low-Dose Triple Antihypertensive Combination Therapy in Patients with Hypertension: A Randomized, Double-Blind, Phase II Study. Drug Des Devel Ther. 2020 Dec 31;14:5735-5746. doi: 10.2147/DDDT.S286586. eCollection 2020.
Other Identifiers
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HM-APOLLO-201
Identifier Type: -
Identifier Source: org_study_id
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