A Phase 4 interventional study of Rosuvastatin and Simvastatin in Diabetes Mellitus and Dyslipidemia, sponsored by Taipei Veterans General Hospital, Taiwan. Completed at 2 sites in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-12-06.
Sponsored by Taipei Veterans General Hospital, Taiwan · Phase 4, Interventional, and Health services research
This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is superior to simvastatin 40 mg in achieving the combined goal of LDL-C (\<100 mg/dL) and non-HDL-C (\<130 mg/dL).
The duration of patient participation will be 18 weeks consisting of a 1-week screening period, a 5-week lead-in period, followed by a 12-week treatment period.
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's enrollment of 90 is close to the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks
Drug: Rosuvastatin
20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
Drug: Simvastatin
10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks
Also known as: crestor
20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
Also known as: zocor
The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment
Time frame: 12 weeks
Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;
Time frame: 4 weeks
Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12;
Time frame: 12 weeks
Percentage of patients achieving the LDL-C goal of <70 mg/dL at Week;The mean percent change from baseline in lipid profile at week 4 and week 12;
Time frame: 12 weeks
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Taipei Veterans General Hospital, Taiwan