Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-29

Study Completion Date

2022-01-31

Brief Summary

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Phase 3 study to evaluate the effiacay and safety of YYC506

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Detailed Description

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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.

Conditions

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Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A multicenter, Double-blind, Randomized, Active-controlled, Double dummy, Parelle-group comparative.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind.

Study Groups

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Test Group

Take both YYC506 and Placebo(Control)

Group Type ACTIVE_COMPARATOR

YYC506

Intervention Type DRUG

YYC506

Control Placebo

Intervention Type DRUG

Placebo

Control Group

Take both Contral and Placebo(YYC506)

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DRUG

Active control

YYC506 Placebo

Intervention Type DRUG

Placebo

Interventions

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YYC506

Intervention Type DRUG

Control

Active control

Intervention Type DRUG

YYC506 Placebo

Placebo

Intervention Type DRUG

Control Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No