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OpenTrials
Completed

NCT Number: NCT06448962

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

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

Completed

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Key information

Conditions

Hypertension, Essential Cardiovascular Diseases Essential Hypertension Hypertension Primary Hypercholesterolemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yonsei Cardiovascular Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Subjects with hypertension and hyperlipidemia

Exclusion criteria

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

Treatment and study plan

AD-2021

Drug

PO, Once daily(QD), 8weeks

AD-2022

Drug

PO, Once daily(QD), 8weeks

AD-2021 Placebo

Drug

PO, Once daily(QD), 8weeks

AD-2022 Placebo

Drug

PO, Once daily(QD), 8weeks

Primary outcomes

  1. 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

  2. Mean sitting systolic blood pressure (MSSBP)

    Time frame: Baseline, Week 8

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

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2024
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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