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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