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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

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ClinicalTrials.gov Identifier: NCT03874260
Recruitment Status : Unknown
Verified March 2019 by Daewon Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 14, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

Study Description
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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
Dyslipidemias Drug: Fenofibrate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 25, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. rate of change for Triglyceride based on baseline [ Time Frame: 8week ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874260


Contacts
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Contact: Jinmin Lee 82-2-2204-7001 jmlee@daewonpharm.com

Locations
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Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital Recruiting
Hwaseong-si, Korea, Republic of
Contact: KYUHYEONG YU         
Sponsors and Collaborators
Daewon Pharmaceutical Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03874260    
Other Study ID Numbers: DWTF-401
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents