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

Addpharma Inc.109 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

109

Conditions

Hypertension, Essential Primary Hypercholesterolemia

Interventions

AD-2021DRUG

PO, Once daily(QD), 8weeks

AD-2022DRUG

PO, Once daily(QD), 8weeks

AD-2021 PlaceboDRUG

PO, Once daily(QD), 8weeks

AD-2022 Placebo

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent * Subjects with hypertension and hyperlipidemia Exclusion Criteria: * Patient with known or suspected secondary hypertension * Other exclusions applied

Locations (1)

Yonsei Cardiovascular Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Low density lipoprotein cholesterol (LDL-C)

LDL-C change at Week 8 compared AD-2021 + AD-2022 with AD-2022

Time frame: Baseline, Week 8

Mean sitting systolic blood pressure (MSSBP)

MSSBP change at Week 8 compared AD-2021 + AD-2022 with AD-2021

Time frame: Baseline, Week 8

Data from ClinicalTrials.gov

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