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

Primary Purpose

Primary Hypercholesterolemia

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AGT2, AGZ
AGT2
AGT4, AGZ
AGT4
Sponsored by
Ahn-Gook Pharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with primary hypercholesterolemia

Exclusion Criteria:

  • The subject not meet the specified LDL-C level

Sites / Locations

  • Yonsei severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

AGT2, AGZ

AGT2

AGT4, AGZ

AGT4

Arm Description

Outcomes

Primary Outcome Measures

% change in LDL-C level from baseline at Week 8
change in LDL-C level

Secondary Outcome Measures

Change in LDL-C level from baseline at Week 4
change in LDL-C level

Full Information

First Posted
January 12, 2022
Last Updated
January 12, 2022
Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05206578
Brief Title
Study to Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
Official Title
To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
July 7, 2022 (Anticipated)
Study Completion Date
September 8, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To Evaluate the Efficacy and Safety of Combination Therapy of AGT and AGZ Versus Monotherapy of AGT in Patients With Primary Hypercholesterolemia.
Detailed Description
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AGT2, AGZ
Arm Type
Experimental
Arm Title
AGT2
Arm Type
Active Comparator
Arm Title
AGT4, AGZ
Arm Type
Experimental
Arm Title
AGT4
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AGT2, AGZ
Intervention Description
Tablet, q.d.
Intervention Type
Drug
Intervention Name(s)
AGT2
Intervention Description
Tablet, q.d.
Intervention Type
Drug
Intervention Name(s)
AGT4, AGZ
Intervention Description
Tablet, q.d.
Intervention Type
Drug
Intervention Name(s)
AGT4
Intervention Description
Tablet, q.d.
Primary Outcome Measure Information:
Title
% change in LDL-C level from baseline at Week 8
Description
change in LDL-C level
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change in LDL-C level from baseline at Week 4
Description
change in LDL-C level
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with primary hypercholesterolemia Exclusion Criteria: The subject not meet the specified LDL-C level
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yumi Hong
Phone
02-3289-4238
Email
ymhelena@ahn-gook.com
Facility Information:
Facility Name
Yonsei severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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