A Study to Evaluate the Efficacy and Safety of Co-administration of AD-2281 and AD-2282
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.
1 other identifier
interventional
110
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
December 24, 2024
CompletedStudy Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedFebruary 4, 2025
February 1, 2025
10 months
December 19, 2024
February 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change rate of LDL-C
Percent change (%) of LDL-C from baseline at week 8
from baseline at 8 weeks
Study Arms (2)
AD-2281 + AD-2282
EXPERIMENTALAD-2281 + Placebo of AD-2282
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Patients with Primary Hypercholesterolemia
You may not qualify if:
- Patients with Secondary Hypercholesterolemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Addpharma Inc.lead
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2024
First Posted
December 24, 2024
Study Start
February 1, 2025
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
February 4, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share