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

NCT ID: NCT06671392

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-24

Study Completion Date

2026-10-31

Brief Summary

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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

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DWC202405

Group Type EXPERIMENTAL

DWC202405

Intervention Type DRUG

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

DWC202405, DWC202314 / DWC202313, DWC202314

Group Type EXPERIMENTAL

DWC202405, DWC202314

Intervention Type DRUG

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

DWC202313, DWC202314

Intervention Type DRUG

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

DWC202405, DWC202314P / DWC202313, DWC202314P

Group Type PLACEBO_COMPARATOR

DWC202405, DWC202314P

Intervention Type DRUG

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

DWC202313, DWC202314P

Intervention Type DRUG

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

Interventions

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DWC202405

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

Intervention Type DRUG

DWC202405, DWC202314

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

Intervention Type DRUG

DWC202405, DWC202314P

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

Intervention Type DRUG

DWC202313, DWC202314

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

Intervention Type DRUG

DWC202313, DWC202314P

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Korea University ANAM Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWJ1622301

Identifier Type: -

Identifier Source: org_study_id