| Trial ID: | L4836 |
| Source ID: | NCT02305355
|
| Associated Drug: |
Omega-3-Acids Ethylesters 90 4g
|
| Title: |
Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Hypertriglycemia
|
| Interventions: |
DRUG: Omega-3-acids ethylesters 90 4g|DRUG: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin
|
| Outcome Measures: |
Primary: The mean percent change of Triglyceride(TG), from baseline at week 16 | Secondary: The mean percent change of Total Cholesterol(TC), from baseline at week 16|The mean percent change of LDL-C, from baseline at week 16|The mean percent change of HDL-C, from baseline at week 16|The mean percent change of HBA1c, from baseline at week 16|The mean percent change of FPG, from baseline at week 16|The mean percent change of hs-CRP, from baseline at week 16|The mean percent change of PAI-1, from baseline at week 16|The mean percent change of Apolipoprotein A1, from baseline at week 16|The mean percent change of apolipoprotein B, from baseline at week 16
|
| Sponsor/Collaborators: |
Sponsor: Kuhnil Pharmaceutical Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
68
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-02
|
| Completion Date: |
2011-02
|
| Results First Posted: |
|
| Last Update Posted: |
2014-12-02
|
| Locations: |
Bucheon St. Mary's Hospital, Bucheon, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02305355
|
