To Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia
HODO-2224
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia
1 other identifier
interventional
125
1 country
1
Brief Summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase 3 trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary Hypercholesterolemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hypertension
Started Apr 2025
Longer than P75 for phase_3 hypertension
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
First Submitted
Initial submission to the registry
October 15, 2024
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedStudy Start
First participant enrolled
April 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedMay 22, 2025
May 1, 2025
27 days
October 15, 2024
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Low density lipoprotein cholesterol (LDL-C)
LDL-C change at Week 8 compared HODO-2224-1 + HODO-2224-4 + HODO-2224-5 with HODO-2224
baseline and week 8
Mean sitting systolic blood pressure (MSSBP)
MSSBP change at week 8 compared HODO-2224-2 + HODO-2224-3 + HODO-2224-6 with HODO-2224
baseline and week 8
Secondary Outcomes (1)
change of other Lipid profile
0, 4, 8 weeks
Study Arms (3)
HODO-2224-1+HODO-2224-2+HODO-2224-4
EXPERIMENTALOral tablet, QD
HODO-2224-1+HODO-2224-4+HODO-2224-5
ACTIVE COMPARATOROral tablet, QD
HODO-2224-2+HODO-2224-3+HODO-2224-6
ACTIVE COMPARATOROral tablet, QD
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 19
- Patients with Essential Hypertension and Primary Hypercholesterolemia
You may not qualify if:
- Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
- Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hyundai Pharmlead
Study Sites (1)
Hanyang University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
October 15, 2024
First Posted
October 17, 2024
Study Start
April 22, 2025
Primary Completion
May 19, 2025
Study Completion (Estimated)
December 31, 2028
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share