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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

Primary Purpose

Dyslipidemias

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fenofibrate
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hallym University Dongtan Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

statin / fenofibrate

statin / fenofibrate placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

rate of change for Triglyceride based on baseline

Secondary Outcome Measures

Full Information

First Posted
March 12, 2019
Last Updated
March 13, 2019
Sponsor
Daewon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03874260
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
statin / fenofibrate
Arm Type
Experimental
Arm Description
stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg)+ choline fenofibrate 178.8mg / once a day, P.O
Arm Title
statin / fenofibrate placebo
Arm Type
Placebo Comparator
Arm Description
stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Other Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
rate of change for Triglyceride based on baseline
Time Frame
8week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinmin Lee
Phone
82-2-2204-7001
Email
jmlee@daewonpharm.com
Facility Information:
Facility Name
Hallym University Dongtan Sacred Heart Hospital
City
Hwaseong-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KYUHYEONG YU

12. IPD Sharing Statement

Citations:
PubMed Identifier
34518033
Citation
Park MS, Youn JC, Kim EJ, Han KH, Lee SH, Kim SH, Kim BJ, Kwon SU, Ryu KH. Efficacy and Safety of Fenofibrate-Statin Combination Therapy in Patients With Inadequately Controlled Triglyceride Levels Despite Previous Statin Monotherapy: A Multicenter, Randomized, Double-blind, Phase IV Study. Clin Ther. 2021 Oct;43(10):1735-1747. doi: 10.1016/j.clinthera.2021.08.005. Epub 2021 Sep 10.
Results Reference
derived

Learn more about this trial

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

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