A Study to Evaluate the Efficacy and Safety of AD-218

Addpharma

Status and phase: Enrolling; Phase 3

Conditions: Mixed Dyslipidemia

Treatments: Drug: AD-218; Drug: AD-218A

Study type: Interventional

Funder types: Industry

Identifiers

NCT05400317

AD-218P3

Details and patient eligibility

About

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

Full description

Condition or disease : Mixed Dyslipidemia Treatment Drug : AD-218, AD-218A, Placebo of AD-218, Placebo of AD-218A

Enrollment: 520 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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520 participants in 2 patient groups

Active Comparator : Test group

Experimental group

Description:

AD-218

Treatment:

Drug: AD-218

Active Comparator : Control group

Active Comparator group

Description:

AD-218A

Treatment:

Drug: AD-218A