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NCT06448962 Clinical Trial

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

Primary Hypercholesterolemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06448962
Other study ID # AD-202P3
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 22, 2020
Est. completion date November 22, 2021

Study information
Verified date June 2024
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 109
Est. completion date November 22, 2021
Est. primary completion date November 22, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Signed informed consent - Subjects with hypertension and hyperlipidemia Exclusion Criteria: - Patient with known or suspected secondary hypertension - Other exclusions applied

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AD-2021
PO, Once daily(QD), 8weeks
• AD-2022
PO, Once daily(QD), 8weeks
• AD-2021 Placebo
PO, Once daily(QD), 8weeks
• AD-2022 Placebo
PO, Once daily(QD), 8weeks

Locations
Country Name City State
Korea, Republic of Yonsei Cardiovascular Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Low density lipoprotein cholesterol (LDL-C) LDL-C change at Week 8 compared AD-2021 + AD-2022 with AD-2022 Baseline, Week 8
Primary Mean sitting systolic blood pressure (MSSBP) MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021 Baseline, Week 8
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