Efficacy and Safety of DWC202404 and DWC202314 in Patients With Hypertension

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

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Hypertension 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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DWC202404 + DWC202314

Group Type EXPERIMENTAL

DWC202404, DWC202314

Intervention Type DRUG

\- 2 tablet, Oral, Once a day

DWC202404 + DWC202314P

Group Type PLACEBO_COMPARATOR

DWC202404, DWC202314P

Intervention Type DRUG

\- 2 tablet, Oral, Once a day

Interventions

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DWC202404, DWC202314

\- 2 tablet, Oral, Once a day

Intervention Type DRUG

DWC202404, DWC202314P

\- 2 tablet, Oral, Once a day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No