Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia
NCT00506961 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2011-12-06
Summary
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).
Conditions
Interventions
- DRUG
-
Rosuvastatin
10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks
- DRUG
-
Simvastatin
20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
Sponsors & Collaborators
-
Taipei Veterans General Hospital, Taiwan
lead OTHER_GOV
Principal Investigators
-
Chii-Min Hwu, MD · Taipei Veterans General Hospital, Taiwan
-
Wayne H Sheu, MD,phD · Taichung Veterans General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-06-30
- Primary Completion
- 2007-07-31
- Completion
- 2007-07-31
Countries
- Taiwan
Study Locations
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