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Clinical Trials/NCT06747936
NCT06747936
Not yet recruiting
Phase 3

A Randomized, Double-blind, Active-controlled, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combined Administration of AD-2281 and AD-2282 in Patients with Primary Hypercholesterolemia.

Addpharma Inc.0 sites110 target enrollmentFebruary 2025
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ConditionsPrimary Hypercholesterolemia
InterventionsAD-2281AD-2282Placebo of AD-2282
DrugsAD-2281AD-2282Placebo of AD-2282

Overview

Phase
Phase 3
Intervention
AD-2281
Conditions
Primary Hypercholesterolemia
Sponsor
Addpharma Inc.
Enrollment
110
Primary Endpoint
Change rate of LDL-C
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safetyof co-administration of AD-2281 and AD-2282 in patients with Primary Hypercholesterolemia

Registry
clinicaltrials.gov
Start Date
February 2025
End Date
December 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Signed informed consent
  • •Patients with Primary Hypercholesterolemia
  • •Other inclusions applied

Exclusion Criteria

  • •Patients with Secondary Hypercholesterolemia
  • •Other exclusions applied

Arms & Interventions

AD-2281 + AD-2282

Intervention: AD-2281

AD-2281 + AD-2282

Intervention: AD-2282

AD-2281 + Placebo of AD-2282

Intervention: AD-2281

AD-2281 + Placebo of AD-2282

Intervention: Placebo of AD-2282

Outcomes

Primary Outcomes

Change rate of LDL-C

Time Frame: from baseline at 8 weeks

Percent change (%) of LDL-C from baseline at week 8

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