NCT05643508

Brief Summary

This study aims to evaluate the efficacy and safety of co-administration of DWC202206 and DWC202207 in patients with concomitant hypertension and hyperlipidemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Feb 2023

Typical duration for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

November 30, 2022

Last Update Submit

April 27, 2026

Conditions

HypertensionHyperlipidemias

Outcome Measures

Primary Outcomes (2)

  • The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm

    8 weeks

  • The change of LDL-C based on baseline between treatment arm and control 2 arm

    8 weeks

Secondary Outcomes (2)

  • The change of MSSBP (Mean Sitting Systolic Blood Pressure) based on baseline between treatment arm and control 1 arm

    4 weeks

  • The change of LDL-C based on baseline between treatment arm and control 2 arm

    4 weeks

Study Arms (3)

(D) DWC202206 + DWC202207

EXPERIMENTAL
Drug: (D) DWC202206Drug: (D) DWC202207

(P+D) DWC202206 + DWC202207

ACTIVE COMPARATOR
Drug: (D) DWC202207Drug: (P) DWC202206

(D+P) DWC202206 + DWC202207

ACTIVE COMPARATOR
Drug: (D) DWC202206Drug: (P) DWC202207

Interventions

(D) DWC202206DRUG

Drug of DWC202206 A mg

(D) DWC202206 + DWC202207(D+P) DWC202206 + DWC202207
(D) DWC202207DRUG

Drug of DWC202207 B/C mg

(D) DWC202206 + DWC202207(P+D) DWC202206 + DWC202207
(P) DWC202206DRUG

Placebo of DWC202206 A mg

(P+D) DWC202206 + DWC202207
(P) DWC202207DRUG

Placebo of DWC202207 B/C mg

(D+P) DWC202206 + DWC202207

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19 to 80 years
  • Patients with hypertension and hyperlipidemias

You may not qualify if:

  • Orthostatic hypotension
  • History of ventricular tachycardia, atrial fibrillation
  • Uncontrolled diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

Fumigant 93

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 8, 2022

Study Start

February 23, 2023

Primary Completion

September 10, 2024

Study Completion

September 10, 2024

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

KR(1)