Clinical Trials Logo
  1. Home
  2. Dyslipidemias
  3. NCT03874260
  4. Details
NCT03874260 Clinical 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

Dyslipidemias Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03874260
Other study ID # DWTF-401
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 25, 2018
Est. completion date March 31, 2020

Study information
Verified date March 2019
Source Daewon Pharmaceutical Co., Ltd.
Contact Jinmin Lee
Phone 82-2-2204-7001
Email jmlee@daewonpharm.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date March 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Hallym University Dongtan Sacred Heart Hospital Hwaseong-si

Sponsors (1)
Lead Sponsor Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary rate of change for Triglyceride based on baseline 8week
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Completed NCT04894318 - The Effect Of Low-Fat And Low-Cholesterol Dietary Intervention On LDL Sub-Groups In Turkısh Dyslipidemic Patients N/A
Completed NCT04862962 - Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia
Completed NCT04052594 - A Study of LY3475766 in Healthy Participants Phase 1
Active, not recruiting NCT04270084 - Metabolic Optimization Through Diet/Lifestyle Improvements For Youth N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04516291 - A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70) Phase 2
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A
Completed NCT04186780 - Effects of Lentinula Edodes Bars on Dyslipidemia and Oxidative Stress in Cholesterol Individuals: Randomized Study N/A
Not yet recruiting NCT03674333 - Effect of Adding Folic Acid on Lipid Parameters in Population With Dyslipidemias N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A
Terminated NCT01697735 - The Therapeutic Effects of Statins and Berberine on the Hyperlipemia Phase 4
Completed NCT00362908 - Effects of Low and Moderate Fat Diets on Lipids, Inflammation and Vascular Reactivity in the Metabolic Syndrome N/A
Completed NCT00455325 - Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS) Phase 2
Completed NCT00644709 - A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD) Phase 4
Recruiting NCT05624658 - Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS N/A
Recruiting NCT03988101 - Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event Phase 4
Recruiting NCT06024291 - Reducing Circulating Sphingolipid Levels to Optimise Cardiometabolic Health - The SphingoFIT Trial N/A
Completed NCT01218204 - A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin Phase 2