Study to Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

NCT ID: NCT05206578

Last Updated: 2022-01-25

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-08

Study Completion Date

2022-09-08

Brief Summary

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To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia.

Detailed Description

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A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

Conditions

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Primary Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AGT2, AGZ

Group Type EXPERIMENTAL

AGT2, AGZ

Intervention Type DRUG

Tablet, q.d.

AGT2

Group Type ACTIVE_COMPARATOR

AGT2

Intervention Type DRUG

Tablet, q.d.

AGT4, AGZ

Group Type EXPERIMENTAL

AGT4, AGZ

Intervention Type DRUG

Tablet, q.d.

AGT4

Group Type ACTIVE_COMPARATOR

AGT4

Intervention Type DRUG

Tablet, q.d.

Interventions

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AGT2, AGZ

Tablet, q.d.

Intervention Type DRUG

AGT2

Tablet, q.d.

Intervention Type DRUG

AGT4, AGZ

Tablet, q.d.

Intervention Type DRUG

AGT4

Tablet, q.d.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with primary hypercholesterolemia

Exclusion Criteria

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

19 Years

Maximum Eligible Age

79 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

Locations

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Yonsei severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yumi Hong

Role: CONTACT

02-3289-4238

Other Identifiers

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AG1901 P3

Identifier Type: -

Identifier Source: org_study_id

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