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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 31, 2020

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: statin / fenofibrate
    • stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg)+ choline fenofibrate 178.8mg / once a day, P.O
  • Placebo Comparator: statin / fenofibrate placebo
    • stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O

Clinical Trial Outcome Measures

Primary Measures

  • rate of change for Triglyceride based on baseline
    • Time Frame: 8week

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daewon Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jinmin Lee, 82-2-2204-7001, jmlee@daewonpharm.com

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