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

Phase 3

Completed

• Conditions: Hypertension, Essential; Primary Hypercholesterolemia
• Interventions: Drug: AD-2021; Drug: AD-2022; Drug: AD-2022 Placebo; Drug: AD-2021 Placebo

• Registration Number: NCT06448962
• Lead Sponsor: Addpharma Inc.

Brief Summary

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

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 Timeline

• Study Start: 2020-10-22
• Primary Completion: 2021-11-22
• Study Completion: 2021-11-22
• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Signed informed consent
• Subjects with hypertension and hyperlipidemia

Read More

Exclusion Criteria

• Patient with known or suspected secondary hypertension
• Other exclusions applied

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental 1	AD-2022	AD-2021, AD-2022
Active Comparator 2	AD-2022	AD-2022, AD-2021 placebo
Experimental 1	AD-2021	AD-2021, AD-2022
Active Comparator 1	AD-2021	AD-2021, AD-2022 placebo
Active Comparator 1	AD-2022 Placebo	AD-2021, AD-2022 placebo
Active Comparator 2	AD-2021 Placebo	AD-2022, AD-2021 placebo

Primary Outcome Measures

Name	Time	Method
Low density lipoprotein cholesterol (LDL-C)	Baseline, Week 8	LDL-C change at Week 8 compared AD-2021 + AD-2022 with AD-2022
Mean sitting systolic blood pressure (MSSBP)	Baseline, Week 8	MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021

Trial Locations

Locations (1)

Yonsei Cardiovascular Hospital; 🇰🇷 Seoul, Korea, Republic of