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Completed

NCT Number: NCT05131997

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

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

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Key information

Conditions

Primary Hypercholesterolemia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yonsei University Hospital

Seoul, Seodaemun-gu, 03722, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Subjects with primary hypercholesterolemia

Exclusion criteria

  • Patient with secondary dyslipidemia
  • Other exclusions applied

Treatment and study plan

AD-221

Drug

PO, Once daily(QD), 8 weeks

AD-221A

Drug

PO, Once daily(QD), 8 weeks

AD-221B

Drug

PO, Once daily(QD), 8 weeks

Other names: Ezetimibe

AD-221C

Drug

PO, Once daily(QD), 8 weeks

Other names: Atorvastatin

Primary outcomes

  1. Low density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline, Week 8

    LDL-C change at Week 8

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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