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

Phase 3

Completed

• Conditions: Primary Hypercholesterolemia
• Interventions: Drug: AD-221A; Drug: AD-221; Drug: AD-221B; Drug: AD-221C

• Registration Number: NCT05131997
• Lead Sponsor: Addpharma Inc.

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

Study Timeline

• Study First Submitted: 2021-11-10
• Study Start: 2021-11-16
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-11-23
• Primary Completion: 2022-06-08
• Study Completion: 2022-06-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Signed informed consent
• Subjects with primary hypercholesterolemia

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Exclusion Criteria

• Patient with secondary dyslipidemia
• Other exclusions applied

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AD-221A	AD-221A	AD-221A, Placebo of AD-221, AD-221B and AD-221C
AD-221	AD-221	AD-221, Placebo of AD-221A, AD-221B and AD-221C
AD-221B	AD-221B	AD-221B, Placebo of AD-221, AD-221A and AD-221C
AD-221C	AD-221C	AD-221C, Placebo of AD-221, AD-221A and AD-221B

Primary Outcome Measures

Name	Time	Method
Low density lipoprotein cholesterol (LDL-C)	Baseline, Week 8	LDL-C change at Week 8

Trial Locations

Locations (1)

Yonsei University Hospital; 🇰🇷 Seoul, Seodaemun-gu, Korea, Republic of