Efficacy and Safety of DWC202404 and DWC202314 in Patients With Hypertension

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

DWC202404, DWC202314

Drug

2 tablet, Oral, Once a day

DWC202404, DWC202314P

Drug

2 tablet, Oral, Once a day

Primary outcomes

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

Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Nov 12, 2024
Registry last updated: May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed