NCT05206578

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2022

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

1.6 years

First QC Date

January 12, 2022

Last Update Submit

January 12, 2022

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

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

    change in LDL-C level

    Week 8

Secondary Outcomes (1)

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

    Week 4

Study Arms (4)

AGT2, AGZ

EXPERIMENTAL
Drug: AGT2, AGZ

AGT2

ACTIVE COMPARATOR
Drug: AGT2

AGT4, AGZ

EXPERIMENTAL
Drug: AGT4, AGZ

AGT4

ACTIVE COMPARATOR
Drug: AGT4

Interventions

AGT2, AGZDRUG

Tablet, q.d.

AGT2, AGZ
AGT2DRUG

Tablet, q.d.

AGT2
AGT4, AGZDRUG

Tablet, q.d.

AGT4, AGZ
AGT4DRUG

Tablet, q.d.

AGT4

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary hypercholesterolemia

You may not qualify if:

  • The subject not meet the specified LDL-C level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei severance Hospital

Seoul, South Korea

RECRUITING

Central Study Contacts

Yumi Hong

CONTACT

02-3289-4238ymhelena@ahn-gook.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 25, 2022

Study Start

December 8, 2020

Primary Completion

July 7, 2022

Study Completion

September 8, 2022

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

KR(1)