NCT05131997

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2021

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

First Submitted

Initial submission to the registry

November 10, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

November 10, 2021

Last Update Submit

July 19, 2022

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Low density lipoprotein cholesterol (LDL-C)

    LDL-C change at Week 8

    Baseline, Week 8

Study Arms (4)

AD-221

EXPERIMENTAL

AD-221, Placebo of AD-221A, AD-221B and AD-221C

Drug: AD-221

AD-221A

EXPERIMENTAL

AD-221A, Placebo of AD-221, AD-221B and AD-221C

Drug: AD-221A

AD-221B

ACTIVE COMPARATOR

AD-221B, Placebo of AD-221, AD-221A and AD-221C

Drug: AD-221B

AD-221C

ACTIVE COMPARATOR

AD-221C, Placebo of AD-221, AD-221A and AD-221B

Drug: AD-221C

Interventions

AD-221DRUG

PO, Once daily(QD), 8 weeks

AD-221
AD-221ADRUG

PO, Once daily(QD), 8 weeks

AD-221A
AD-221BDRUG

PO, Once daily(QD), 8 weeks

Also known as: Ezetimibe
AD-221B
AD-221CDRUG

PO, Once daily(QD), 8 weeks

Also known as: Atorvastatin
AD-221C

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • Subjects with primary hypercholesterolemia

You may not qualify if:

  • Patient with secondary dyslipidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Interventions

EzetimibeAtorvastatin

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Sang Hak Lee, M.D., Ph.D

    Yonsei University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 10, 2021

First Posted

November 23, 2021

Study Start

November 16, 2021

Primary Completion

June 8, 2022

Study Completion

June 8, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)