NCT06448962

Brief Summary

The purpose of this study is to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

October 22, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

June 3, 2024

Last Update Submit

June 3, 2024

Conditions

Hypertension, EssentialPrimary Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

  • Low density lipoprotein cholesterol (LDL-C)

    LDL-C change at Week 8 compared AD-2021 + AD-2022 with AD-2022

    Baseline, Week 8

  • Mean sitting systolic blood pressure (MSSBP)

    MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021

    Baseline, Week 8

Study Arms (3)

Experimental 1

EXPERIMENTAL

AD-2021, AD-2022

Drug: AD-2021Drug: AD-2022

Active Comparator 1

ACTIVE COMPARATOR

AD-2021, AD-2022 placebo

Drug: AD-2021Drug: AD-2022 Placebo

Active Comparator 2

ACTIVE COMPARATOR

AD-2022, AD-2021 placebo

Drug: AD-2022Drug: AD-2021 Placebo

Interventions

AD-2021DRUG

PO, Once daily(QD), 8weeks

Active Comparator 1Experimental 1
AD-2022DRUG

PO, Once daily(QD), 8weeks

Active Comparator 2Experimental 1
AD-2021 PlaceboDRUG

PO, Once daily(QD), 8weeks

Active Comparator 2
AD-2022 PlaceboDRUG

PO, Once daily(QD), 8weeks

Active Comparator 1

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • Subjects with hypertension and hyperlipidemia

You may not qualify if:

  • Patient with known or suspected secondary hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei Cardiovascular Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Seok Min Kang, M.D., Ph.D

    Yonsei Cardiovascular Hospital

    PRINCIPAL INVESTIGATOR

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

June 3, 2024

First Posted

June 7, 2024

Study Start

October 22, 2020

Primary Completion

November 22, 2021

Study Completion

November 22, 2021

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)