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NCT05131997 Clinical Trial

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

Primary Hypercholesterolemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05131997
Other study ID # AD-221P3
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 16, 2021
Est. completion date June 8, 2022

Study information
Verified date July 2022
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 290
Est. completion date June 8, 2022
Est. primary completion date June 8, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Signed informed consent - Subjects with primary hypercholesterolemia Exclusion Criteria: - Patient with secondary dyslipidemia - Other exclusions applied

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AD-221
PO, Once daily(QD), 8 weeks
• AD-221A
PO, Once daily(QD), 8 weeks
• AD-221B
PO, Once daily(QD), 8 weeks
• AD-221C
PO, Once daily(QD), 8 weeks

Locations
Country Name City State
Korea, Republic of Yonsei University Hospital Seoul Seodaemun-gu

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Low density lipoprotein cholesterol (LDL-C) LDL-C change at Week 8 Baseline, Week 8
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