NCT06682000

Brief Summary

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of DWC202404 and DWC202314 Combination Therapy in Patients with Essential Hypertension Inadequately Controlled on DWC202404 Monotherapy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

November 7, 2024

Last Update Submit

February 4, 2026

Conditions

HypertensionEssential Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline

    8 weeks

Study Arms (2)

DWC202404 + DWC202314

EXPERIMENTAL
Drug: DWC202404, DWC202314

DWC202404 + DWC202314P

PLACEBO COMPARATOR
Drug: DWC202404, DWC202314P

Interventions

DWC202404, DWC202314DRUG

\- 2 tablet, Oral, Once a day

DWC202404 + DWC202314
DWC202404, DWC202314PDRUG

\- 2 tablet, Oral, Once a day

DWC202404 + DWC202314P

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Average systolic blood pressure (MSSBP) measured at the time of screening meet the following criteria (a) If anti-hypertensive drugs are not being administered: 140 mmHg ≤ MSSBP \< 180 mmHg (b) If anti-hypertensive drugs are being administered: 130 mmHg ≤ MSSBP \< 180 mmHg

You may not qualify if:

  • If the blood pressure measured at the time of screening and randomization is 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)

Hanyang University Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionEssential Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

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 7, 2024

First Posted

November 12, 2024

Study Start

January 1, 2025

Primary Completion

October 2, 2025

Study Completion

October 2, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

KR(1)