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

Daewon Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Dyslipidemias

Treatments: Drug: Fenofibrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03874260

DWTF-401

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

statin / fenofibrate

Experimental group

Description:

stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg)+ choline fenofibrate 178.8mg / once a day, P.O

Treatment:

Drug: Fenofibrate

statin / fenofibrate placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Fenofibrate