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

Daewoong Pharmaceutical

Status and phase: Active, not recruiting; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: DWC202313, DWC202314P; Drug: DWC202405; Drug: DWC202405, DWC202314P; Drug: DWC202313, DWC202314; Drug: DWC202405, DWC202314

Study type: Interventional

Funder types: Industry

Identifiers

NCT06671392

DW_DWJ1622301

Details and patient eligibility

About

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

Enrollment: 192 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 participants in 3 patient groups, including a placebo group

DWC202405

Experimental group

Treatment:

Drug: DWC202405

DWC202405, DWC202314 / DWC202313, DWC202314

Experimental group

Treatment:

Drug: DWC202405, DWC202314

Drug: DWC202313, DWC202314

DWC202405, DWC202314P / DWC202313, DWC202314P

Placebo Comparator group

Treatment:

Drug: DWC202405, DWC202314P

Drug: DWC202313, DWC202314P