A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A

Addpharma

Status and phase: Completed; Phase 3

Conditions: Primary Hypercholesterolemia

Treatments: Drug: AD-221A; Drug: AD-221C; Drug: AD-221B; Drug: AD-221

Study type: Interventional

Funder types: Industry

Identifiers

NCT05131997

AD-221P3

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A

Full description

The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A in patients with primary hypercholesterolemia

Enrollment: 290 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Subjects with primary hypercholesterolemia

Exclusion criteria

• Patient with secondary dyslipidemia
• Other exclusions applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 4 patient groups

AD-221

Experimental group

Description:

AD-221, Placebo of AD-221A, AD-221B and AD-221C

Treatment:

Drug: AD-221

AD-221A

Experimental group

Description:

AD-221A, Placebo of AD-221, AD-221B and AD-221C

Treatment:

Drug: AD-221A

AD-221B

Active Comparator group

Description:

AD-221B, Placebo of AD-221, AD-221A and AD-221C

Treatment:

Drug: AD-221B

AD-221C

Active Comparator group

Description:

AD-221C, Placebo of AD-221, AD-221A and AD-221B

Treatment:

Drug: AD-221C