Clinical trial

A Randomized, Double-blinded, Active-controlled, Multicenter Phase 3 Clinical Trial and Open-label, Extension Study to Evaluate the Efficacy and Safety of AD-218 in Patients With Mixed Dyslipidemia

NCT05400317

Name

AD-218P3

Description

The purpose of this study is to evaluate the efficacy and safety of AD-218

Trial arms

Trial start

2022-07-27

Estimated PCD

2025-03-31

Trial end

2025-06-30

Status

Recruiting

Phase

Early phase I

Treatment

AD-218

PO, Once daily(QD), 12weeks

Arms:

Active Comparator : Test group

AD-218A

PO, Once daily(QD), 12weeks

Arms:

Active Comparator : Control group

Size

520

Primary endpoint

Percent change (%) of non-HDL-C from baseline at week 12

from baseline at 12 weeks

Eligibility criteria

Inclusion Criteria: * A man or woman over 19 years old. * Sign on ICF prior to study participation Exclusion Criteria: * History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN) * Other exclusions applied

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 520, 'type': 'ESTIMATED'}}

Updated at

2024-01-31

1 organization

2 products

1 indication

Product

Indication

Product

Organization