Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506. (Atorf-YOOrct)

YooYoung Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Dyslipidemias

Treatments: Drug: YYC506 Placebo; Drug: Control; Drug: YYC506; Drug: Control Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04858308

YYPCT_YYC506_301

Details and patient eligibility

About

Phase 3 study to evaluate the effiacay and safety of YYC506

Full description

Phase 3 study to evaluate the effiacay and safety of YYC506 in patients with complex dyslipidemia where LDL-C is properly controlled but TG and HDL-C levels are not regulated by Atorvastatin alone.

Enrollment: 554 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A man or woman over 19 years old.
• LDL-C properly controlled, TG, HDL-C is not properly controlled
• Sign on ICF prior to study participation

Exclusion criteria

• History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN)
• Uncontrolled hypo-thyroidism (TSH≥1.5XULN)
• Severe renal impairemnet (Creainine clearance < 30mL/min) etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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554 participants in 2 patient groups

Test Group

Active Comparator group

Description:

Take both YYC506 and Placebo(Control)

Treatment:

Drug: Control Placebo

Drug: YYC506

Control Group

Active Comparator group

Description:

Take both Contral and Placebo(YYC506)

Treatment:

Drug: Control

Drug: YYC506 Placebo