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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05206578
Enrollment
264
Registered
2022-01-25
Start date
2020-12-08
Completion date
2022-09-08
Last updated
2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypercholesterolemia

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

Interventions

DRUGAGT2, AGZ

Tablet, q.d.

DRUGAGT2

Tablet, q.d.

DRUGAGT4, AGZ

Tablet, q.d.

DRUGAGT4

Tablet, q.d.

Sponsors

Ahn-Gook Pharmaceuticals Co.,Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* Patients with primary hypercholesterolemia

Exclusion criteria

* The subject not meet the specified LDL-C level

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Contacts

Primary ContactYumi Hong
ymhelena@ahn-gook.com02-3289-4238

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026