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A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R

NCT ID: NCT06717360

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-06-30

Brief Summary

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A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients with Primary Hypercholesterolemia

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AG2304T

Group Type EXPERIMENTAL

AG2304T

Intervention Type DRUG

AG2304T, QD, PO

AG2304R

Group Type ACTIVE_COMPARATOR

AG2304R

Intervention Type DRUG

AG2304R, QD, PO

Interventions

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AG2304T

AG2304T, QD, PO

Intervention Type DRUG

AG2304R

AG2304R, QD, PO

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults aged 19-80
* Patients with primary hypercholesterolemia
* Those who voluntarily written consent to participate in this clinical trial

Exclusion Criteria

* The subject not meet the specified LDL-C level
* Other exclusions applied
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahn-Gook Pharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Soyeon Jeong

Role: CONTACT

Phone: +82-2-3289-4359

Email: [email protected]

Other Identifiers

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AG2304 P3

Identifier Type: -

Identifier Source: org_study_id