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

July 19, 2022 updated by: Addpharma Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Subjects with primary hypercholesterolemia

Exclusion Criteria:

  • Patient with secondary dyslipidemia
  • Other exclusions applied

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AD-221
AD-221, Placebo of AD-221A, AD-221B and AD-221C
Drug: AD-221
PO, Once daily(QD), 8 weeks
Experimental: AD-221A
AD-221A, Placebo of AD-221, AD-221B and AD-221C
Drug: AD-221A
PO, Once daily(QD), 8 weeks
Active Comparator: AD-221B
AD-221B, Placebo of AD-221, AD-221A and AD-221C
Drug: AD-221B
PO, Once daily(QD), 8 weeks
Other Names:
  • Ezetimibe
Active Comparator: AD-221C
AD-221C, Placebo of AD-221, AD-221A and AD-221B
Drug: AD-221C
PO, Once daily(QD), 8 weeks
Other Names:
  • Atorvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline, Week 8
LDL-C change at Week 8
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Investigators

  • Principal Investigator: Sang Hak Lee, M.D., Ph.D, Yonsei University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2021

Primary Completion (Actual)

June 8, 2022

Study Completion (Actual)

June 8, 2022

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-221P3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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