Cinical Trial to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy

A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03874260

Enrollment

180

Registered

2019-03-14

Start date

2018-07-25

Completion date

2020-03-31

Last updated

2019-03-15

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

Conditions

Dyslipidemias

Brief summary

Interventions

DRUGFenofibrate

statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate vs statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* both male and female who are over 19-year-old * 200mg/dl≤TG\<500mg/dl * Desired value of LDL-c 1. very high risk \< 70 2. high risk \< 100 3. moderate risk \<130 4. low risk \< 160

Exclusion criteria

* patient who is going to have an operation during this study * patient who has allergy or hypersensitivity of fenofibrate * patient who has abnormal ECG

Design outcomes

Primary

Measure	Time frame
rate of change for Triglyceride based on baseline	8week

Countries

South Korea

Contacts

Primary ContactJinmin Lee

jmlee@daewonpharm.com82-2-2204-7001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026