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Clinical Trials/NCT05400317
NCT05400317
Recruiting
Phase 3

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

Addpharma Inc.1 site in 1 country520 target enrollmentJuly 27, 2022
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ConditionsMixed Dyslipidemia
InterventionsAD-218AD-218A
DrugsAD-218AD-218A

Overview

Phase
Phase 3
Intervention
AD-218
Conditions
Mixed Dyslipidemia
Sponsor
Addpharma Inc.
Enrollment
520
Locations
1
Primary Endpoint
Percent change (%) of non-HDL-C from baseline at week 12
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
July 27, 2022
End Date
June 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Active Comparator : Test group

AD-218

Intervention: AD-218

Active Comparator : Control group

AD-218A

Intervention: AD-218A

Outcomes

Primary Outcomes

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

Time Frame: from baseline at 12 weeks

non-HDL-C at week 12 compared AD-218 with AD-218A

Secondary Outcomes

  • Percent change (%) of non-HDL-C from baseline at week 4, 8(from baseline at week 4,8)
  • Percent change (%) of Lipid panel from baseline at week 4, 8, 12(from baseline at week 4, 8, 12)

Study Sites (1)

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