Clinical Trial Details
| Trial ID: | L4404 |
| Source ID: | NCT01185236 |
| Associated Drug: | Simvastatin/Ezetimibe |
| Title: | Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus Without Insulin Treatment |
| Interventions: | DRUG: simvastatin/ezetimibe|DRUG: atorvastatin 20mg |
| Outcome Measures: | Primary: change of ApoB/ApoA1, change of ApoB/ApoA1, after 12 weeks' treatment | Secondary: change of lipid profile, change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48, 12weeks|change of HbA1c, change of HbA1c, 12weeks|change of HOMA index, HOMA =\[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)\] / 22.5, 12weeks|change of hsCRP, change of hsCRP, 12weeks|safety, CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms, during 12weeks of treatment |
| Sponsor/Collaborators: | Sponsor: Seoul National University Hospital | Collaborators: Merck Sharp & Dohme LLC |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 132 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2010-09 |
| Completion Date: | 2011-08 |
| Results First Posted: | |
| Last Update Posted: | 2010-08-19 |
| Locations: | Seoul national university hospital, Seoul, 110744, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT01185236 |
