Overview

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

Status:
Unknown status
Trial end date:
2020-03-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Daewon Pharmaceutical Co., Ltd.
Treatments:
Choline
Fenofibrate
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Criteria
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