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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

Sponsor
Daewon Pharmaceutical Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03874260
Collaborator
(none)
180
Enrollment
1
Location
2
Arms
20.2
Anticipated Duration (Months)
8.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 25, 2018
Anticipated Primary Completion Date :
Jan 31, 2020
Anticipated Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: statin / fenofibrate

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

Drug: Fenofibrate
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
Other Names:
  • placebo

    		•
    Placebo Comparator: statin / fenofibrate placebo

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

    Drug: Fenofibrate
    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
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. rate of change for Triglyceride based on baseline [8week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hallym University Dongtan Sacred Heart Hospital Hwaseong-si Korea, Republic of

    Sponsors and Collaborators

    • Daewon Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewon Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03874260
    Other Study ID Numbers:
    • DWTF-401
    First Posted:
    Mar 14, 2019
    Last Update Posted:
    Mar 15, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dyslipidemias
    Fenofibrate

    Study Results

    No Results Posted as of Mar 15, 2019