A Phase III Study to Efficacy and Safety of DWC202405/DWC202313 and DWC202314 in Patients with Hypertension

Phase 3

Recruiting

• Conditions: Essential Hypertension
• Interventions: Drug: DWC202405; Drug: DWC202405, DWC202314; Drug: DWC202405, DWC202314P; Drug: DWC202313, DWC202314; Drug: DWC202313, DWC202314P

• Registration Number: NCT06671392
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Study Start: 2025-02-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWC202405	DWC202405	-
DWC202405, DWC202314 / DWC202313, DWC202314	DWC202405, DWC202314	-
DWC202405, DWC202314 / DWC202313, DWC202314	DWC202313, DWC202314	-
DWC202405, DWC202314P / DWC202313, DWC202314P	DWC202405, DWC202314P	-
DWC202405, DWC202314P / DWC202313, DWC202314P	DWC202313, DWC202314P	-

Primary Outcome Measures

Name	Time	Method
change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline	8 weeks

Trial Locations

Locations (1)

Korea University ANAM Hospital; 🇰🇷 Seoul, Korea, Republic of