A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
1 other identifier
interventional
340
1 country
1
Brief Summary
A phase 3 study to evaluate efficacy and safety of HCP1401
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 27, 2016
CompletedOctober 20, 2016
September 1, 2016
1.4 years
September 26, 2016
October 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in sitting systolic blood pressure at week 8
8 weeks
Secondary Outcomes (3)
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
Study Arms (2)
Treatment
EXPERIMENTALHCP1401
Reference
ACTIVE COMPARATORHCP0605
Interventions
Eligibility Criteria
You may qualify if:
- Hypertension patient who satisfied below condition at Visit 1.
- patient who takes antihypertensive drug
- mmHg \<= sitSBP \<= 200mmHg
- patient who doesn't take antihypertensive drug
- mmHg \<= sitSBP \<= 200mmHg
- mmHg \<= sitSBP \<= 200mmHg at Visit 2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related Publications (1)
Hong SJ, Jeong HS, Han SH, Chang KY, Hong BK, Lee BK, Chae SC, Kim WS, Park CG, Heo JH, Lee SU, Kim YD, Kim KS, Choi JH, Kang HJ, Kim JJ, Kang SM, Choi YJ, Shin JH, Chun KJ, Shin DG, Park SH, Kwan J, Choi YJ, Jeong MH, Chae JK, Kim DW, Cho JR, Han KR, Won KH, Park SH, Lee SK, Kim SH, Jung J, Kim CH. Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2017 Oct;39(10):2049-2060. doi: 10.1016/j.clinthera.2017.08.013. Epub 2017 Sep 19.
PMID: 28939406DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheulho Kim, M.D.,Ph.D.
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2016
First Posted
September 27, 2016
Study Start
April 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 20, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share