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

Phase 3

• Conditions: Primary Hypercholesterolemia
• Interventions: Drug: AGT2, AGZ; Drug: AGT2; Drug: AGT4, AGZ; Drug: AGT4

• Registration Number: NCT05206578
• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

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

Study Timeline

• Study Start: 2020-12-08
• Status Verified: 2022-01
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-25
• Last Update Posted: 2022-01-25
• Primary Completion: 2022-07-07
• Study Completion: 2022-09-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• Patients with primary hypercholesterolemia

Exclusion Criteria

• The subject not meet the specified LDL-C level

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
AGT2, AGZ	AGT2, AGZ	-
AGT2	AGT2	-
AGT4, AGZ	AGT4, AGZ	-
AGT4	AGT4	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yonsei severance Hospital; 🇰🇷 Seoul, Korea, Republic of