Health TrialsbyHealthPanel

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

ConditionMixed Dyslipidemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorAddpharma Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A man or woman over 19 years old.

Sign on ICF prior to study participation

Disqualifiers

History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN)

Other exclusions applied

Trial design

Design model

Parallel

Treatments tested in this trial

  • AD-218

    Drug

    PO, Once daily(QD), 12weeks

  • AD-218A

    Drug

    PO, Once daily(QD), 12weeks

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: Active Comparator : Test groupExperimental treatment 1 intervention
Group B: Active Comparator : Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
from baseline at 12 weeks

Secondary outcomes

1

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

non-HDL-C at week 4,8 compared AD-218 with AD-218A

Time frame
from baseline at week 4,8
2

Percent change (%) of Lipid panel from baseline at week 4, 8, 12

Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A

Time frame
from baseline at week 4, 8, 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Addpharma Inc.

Lead sponsor

Source ClinicalTrials.gov
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