CClinicalTrials.gg
CompletedNCT05131997Updated Jul 20, 2022

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

A Phase 3 interventional study of AD-221 and AD-221A in Primary Hypercholesterolemia, sponsored by Addpharma Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Addpharma Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
290
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Primary Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 290 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Addpharma Inc. is the lead sponsor of 56 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Signed informed consent
  • Subjects with primary hypercholesterolemia

Exclusion criteria

Exclusion Criteria:

  • Patient with secondary dyslipidemia
  • Other exclusions applied
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
290 participants (actual)

Study arms

  • Experimental
    AD-221

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

    Drug: AD-221

  • Experimental
    AD-221A

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

    Drug: AD-221A

  • Active comparator
    AD-221B

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

    Drug: AD-221B

  • Active comparator
    AD-221C

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

    Drug: AD-221C

Interventions

  • DrugAD-221

    PO, Once daily(QD), 8 weeks

  • DrugAD-221A

    PO, Once daily(QD), 8 weeks

  • DrugAD-221B

    PO, Once daily(QD), 8 weeks

    Also known as: Ezetimibe

  • DrugAD-221C

    PO, Once daily(QD), 8 weeks

    Also known as: Atorvastatin

06

What researchers measure

Primary outcomes

  1. Low density lipoprotein cholesterol (LDL-C)

    LDL-C change at Week 8

    Time frame: Baseline, Week 8

07

Study locations

1 site
  • Yonsei University Hospital
    Seoul, Seodaemun-gu 03722, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05131997
Lead sponsor
Addpharma Inc.
Responsible party
Sponsor
First posted
Nov 23, 2021
Start date
Nov 16, 2021
Primary completion
Jun 8, 2022
Completion
Jun 8, 2022
Last update
Jul 20, 2022

Study contacts

Sang Hak Lee, M.D., Ph.D
principal investigator · Yonsei University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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