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
- Registration Number
- NCT03874260
- Lead Sponsor
- Daewon Pharmaceutical Co., Ltd.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
-
both male and female who are over 19-year-old
-
200mg/dl≤TG<500mg/dl
-
Desired value of LDL-c
- very high risk < 70
- high risk < 100
- moderate risk <130
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description statin / fenofibrate Fenofibrate stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg)+ choline fenofibrate 178.8mg / once a day, P.O statin / fenofibrate placebo Fenofibrate stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O
- Primary Outcome Measures
Name Time Method rate of change for Triglyceride based on baseline 8week
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hallym University Dongtan Sacred Heart Hospital
🇰🇷Hwaseong-si, Korea, Republic of