A Study to Evaluate the Efficacy and Safety of Co-administration of AD-2281 and AD-2282

The purpose of this study is to evaluate the efficacy and safetyof co-administration of AD-2281 and AD-2282 in patients with Primary Hypercholesterolemia

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Key information

Conditions

Primary Hypercholesterolemia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

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
Patients with Primary Hypercholesterolemia
Other inclusions applied

Exclusion criteria

Patients with Secondary Hypercholesterolemia
Other exclusions applied

Treatment and study plan

AD-2281

Drug

PO, Once daily, 8weeks

AD-2282

Drug

PO, Once daily, 8weeks

Placebo of AD-2282

Drug

PO, Once daily, 8weeks

Primary outcomes

Change rate of LDL-C

Time frame: from baseline at 8 weeks

Percent change (%) of LDL-C from baseline at week 8

Study contacts

Contact information is provided by the study sponsor or research team.

JeongEun Park

CONTACT

[email protected]

+82-31-891-6989

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Active-controlled, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combined Administration of AD-2281 and AD-2282 in Patients with Primary Hypercholesterolemia.

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Dec 24, 2024
Registry last updated: Feb 4, 2025

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.

Published trials that share one or more normalized conditions with this study.

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