Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022

June 3, 2024 updated by: Addpharma Inc.

A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022 in Patients With Primary Hypercholesterolemia and Essential Hypertension

The purpose of this study is to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Condition or disease : Primary Hypercholesterolemia and Essential Hypertension Intervention/treatment Drug : AD-2021 Drug : AD-2022 Drug : AD-2021 Placebo Drug : AD-2022 Placebo Phase : Phase 3

Study Type

Interventional

Enrollment (Actual)

109

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent
  • Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

  • Patient with known or suspected secondary hypertension
  • 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental 1
AD-2021, AD-2022
Drug: AD-2021
PO, Once daily(QD), 8weeks
Drug: AD-2022
PO, Once daily(QD), 8weeks
Active Comparator: Active Comparator 1
AD-2021, AD-2022 placebo
Drug: AD-2021
PO, Once daily(QD), 8weeks
Drug: AD-2022 Placebo
PO, Once daily(QD), 8weeks
Active Comparator: Active Comparator 2
AD-2022, AD-2021 placebo
Drug: AD-2022
PO, Once daily(QD), 8weeks
Drug: AD-2021 Placebo
PO, Once daily(QD), 8weeks

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 compared AD-2021 + AD-2022 with AD-2022
Baseline, Week 8
Mean sitting systolic blood pressure (MSSBP)
Time Frame: Baseline, Week 8
MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021
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: Seok Min Kang, M.D., Ph.D, Yonsei Cardiovascular 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)

October 22, 2020

Primary Completion (Actual)

November 22, 2021

Study Completion (Actual)

November 22, 2021

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-202P3

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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