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Clinical Trials/NCT05131997
NCT05131997
Completed
Phase 3

A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Administrated AD-221 and AD-221A in Patients With Primary Hypercholesterolemia

Addpharma Inc.1 site in 1 country290 target enrollmentNovember 16, 2021
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ConditionsPrimary Hypercholesterolemia
InterventionsAD-221CAD-221AD-221AAD-221B
DrugsAD-221AD-221AAD-221BAD-221C

Overview

Phase
Phase 3
Intervention
AD-221C
Conditions
Primary Hypercholesterolemia
Sponsor
Addpharma Inc.
Enrollment
290
Locations
1
Primary Endpoint
Low density lipoprotein cholesterol (LDL-C)
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
November 16, 2021
End Date
June 8, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Signed informed consent
  • •Subjects with primary hypercholesterolemia

Exclusion Criteria

  • •Patient with secondary dyslipidemia
  • •Other exclusions applied

Arms & Interventions

AD-221C

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

Intervention: AD-221C

AD-221

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

Intervention: AD-221

AD-221A

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

Intervention: AD-221A

AD-221B

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

Intervention: AD-221B

Outcomes

Primary Outcomes

Low density lipoprotein cholesterol (LDL-C)

Time Frame: Baseline, Week 8

LDL-C change at Week 8

Study Sites (1)

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