Study to Evaluate the Efficacy and Safety in Patients Wit... | NCT05206578

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

NCT05206578

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Status

Unknown status

Last Update Posted

Jan 25, 2022Actual

Enrollment

264Estimated

Phase

Phase 3

Conditions

Primary Hypercholesterolemia

Interventions

AGT2, AGZ
AGT2
AGT4, AGZ
AGT4

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 2020Actual

Primary Completion Date

Jul 7, 2022Estimated

Completion Date

Sep 8, 2022Estimated

First Submitted Date

Jan 12, 2022

First Submission Date that Met QC Criteria

Jan 12, 2022

First Posted Date

Jan 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2022

Last Update Posted Date

Jan 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

264Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
AGT2, AGZ	Experimental	Drug: AGT2, AGZ
AGT2	Active Comparator	Drug: AGT2
AGT4, AGZ	Experimental	Drug: AGT4, AGZ
AGT4	Active Comparator	Drug: AGT4

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AGT2, AGZ	Drug	Tablet, q.d.	AGT2, AGZ
AGT2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
% change in LDL-C level from baseline at Week 8	change in LDL-C level	Week 8

Secondary Outcomes

Measure	Description	Time Frame
Change in LDL-C level from baseline at Week 4	change in LDL-C level	Week 4

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with primary hypercholesterolemia

Exclusion Criteria:

The subject not meet the specified LDL-C level

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yumi Hong	Contact	02-3289-4238		ymhelena@ahn-gook.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei severance Hospital	Recruiting	Seoul			South Korea