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

Ahn-Gook Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Primary Hypercholesterolemia

Treatments: Drug: AGT2, AGZ; Drug: AGT2; Drug: AGT4; Drug: AGT4, AGZ

Study type: Interventional

Funder types: Industry

Identifiers

NCT05206578

AG1901 P3

Details and patient eligibility

About

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

Full description

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

Enrollment: 264 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with primary hypercholesterolemia

Exclusion criteria

• The subject not meet the specified LDL-C level

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

264 participants in 4 patient groups

AGT2, AGZ

Experimental group

Treatment:

Drug: AGT2, AGZ

AGT2

Active Comparator group

Treatment:

Drug: AGT2

AGT4, AGZ

Experimental group

Treatment:

Drug: AGT4, AGZ

AGT4

Active Comparator group

Treatment:

Drug: AGT4