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Completed

NCT Number: NCT06671392

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

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University ANAM Hospital

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) 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.

Exclusion criteria

  • 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

Treatment and study plan

DWC202405

Drug

5/20mg, 1 tablet, Oral, Once a day

DWC202405, DWC202314

Drug

5/20mg + 1.5mg, 1 tablet, Oral, Once a day

DWC202405, DWC202314P

Drug

5/20mg + 1.5mg, 1 tablet, Oral, Once a day

DWC202313, DWC202314

Drug

10/40mg + 1.5mg, 1 tablet, Oral, Once a day

DWC202313, DWC202314P

Drug

10/40mg + 1.5mg, 1 tablet, Oral, Once a day

Primary outcomes

  1. 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 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Mar 19, 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.

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