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

A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Administrated AD-221 and AD-221A in Patients With Primary Hypercholesterolemia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05131997
Enrollment
290
Registered
2021-11-23
Start date
2021-11-16
Completion date
2022-06-08
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypercholesterolemia

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

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

DRUGAD-221C

PO, Once daily(QD), 8 weeks

Sponsors

Addpharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Signed informed consent * Subjects with primary hypercholesterolemia

Exclusion criteria

* Patient with secondary dyslipidemia * Other exclusions applied

Design outcomes

Primary

MeasureTime frameDescription
Low density lipoprotein cholesterol (LDL-C)Baseline, Week 8LDL-C change at Week 8

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026