A Phase III Study to Efficacy and Safety of DWC202405/DWC202313 and DWC202314 in Patients With Hypertension
A Multi-center, Randomized, Double-blind, Parallel Design, Phase III Study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients With Essential Hypertension Inadequately Controlled With DWC202405
1 other identifier
interventional
198
1 country
1
Brief Summary
A Multi-center, Randomized, Double-blind, Parallel design, Phase III study to Evaluate and Compare the Efficacy and Safety of DWC202405/DWC202313 and DWC202314 Combination Therapy to DWC202405/DWC202313 in Patients with Essential Hypertension Inadequately Controlled with DWC202405
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2025
Shorter than P25 for phase_3
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
November 1, 2024
CompletedFirst Posted
Study publicly available on registry
November 4, 2024
CompletedStudy Start
First participant enrolled
February 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2026
CompletedMarch 19, 2026
March 1, 2026
12 months
November 1, 2024
March 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline
8 weeks
Study Arms (3)
DWC202405
EXPERIMENTALDWC202405, DWC202314 / DWC202313, DWC202314
EXPERIMENTALDWC202405, DWC202314P / DWC202313, DWC202314P
PLACEBO COMPARATORInterventions
5/20mg + 1.5mg, 1 tablet, Oral, Once a day
5/20mg + 1.5mg, 1 tablet, Oral, Once a day
10/40mg + 1.5mg, 1 tablet, Oral, Once a day
10/40mg + 1.5mg, 1 tablet, Oral, Once a day
Eligibility Criteria
You may qualify if:
- Average systolic blood pressure (MSSBP) and average diastolic blood pressure (MSDBP) measured at the time of screening meet the following criteria (a) If antihypertensive drugs are being administered: 140 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg However, the criteria of 130 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg are applied to patients with the following diseases.
You may not qualify if:
- If the blood pressure measured at the time of screening and randomization is MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg
- Those whose blood pressure differences measured on both arms at the time of screening are MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University ANAM Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition 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
November 1, 2024
First Posted
November 4, 2024
Study Start
February 24, 2025
Primary Completion
February 5, 2026
Study Completion
February 5, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03