A Study to Evaluate the Efficacy and Safety of AD-221 and... | NCT05131997

Studies
A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A

NCT05131997

Sponsor

Addpharma Inc.

Status

Completed

Last Update Posted

Jul 20, 2022Actual

Enrollment

290Actual

Phase

Phase 3

Conditions

Primary Hypercholesterolemia

Interventions

AD-221
AD-221A
AD-221B
AD-221C

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2021Actual

Primary Completion Date

Jun 8, 2022Actual

Completion Date

Jun 8, 2022Actual

First Submitted Date

Nov 10, 2021

First Submission Date that Met QC Criteria

Nov 22, 2021

First Posted Date

Nov 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2022

Last Update Posted Date

Jul 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A in patients with primary hypercholesterolemia

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

290Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
AD-221	Drug	PO, Once daily(QD), 8 weeks	AD-221
AD-221A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Low density lipoprotein cholesterol (LDL-C)	LDL-C change at Week 8	Baseline, Week 8

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Subjects with primary hypercholesterolemia

Exclusion Criteria:

Patient with secondary dyslipidemia
Other exclusions applied

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sang Hak Lee, M.D., Ph.D	Yonsei University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University Hospital		Seoul	Seodaemun-gu	03722	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069438	Ezetimibe
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided