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Pitavastatin versus atorvastatin in type 2 diabetes mellitus with combined dyslipidemia
2005-001038-34Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2006
- Countries
- 1
- Sponsor
- Kowa Research Europe
- Modality
- Small Molecules
- Conditions
- combined dyslipidaemiatype 2 diabetes mellitus (T2DM)
01
Overview
Phase 3 trial of pitavastatin and atorvastatin in combined dyslipidaemia and type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Kowa Research Europe. Started Jan 2006; status: completed.
02
Design
2 armsPitavastatin arm
Pitavastatin monotherapy with up-titration to 4 mg once daily.
Atorvastatin arm
Atorvastatin monotherapy with up-titration to 20 mg once daily.
03
Who it enrols
Adults aged 18 to 75 years with type 2 diabetes mellitus and combined dyslipidemia were eligible. Patients with homozygous familial hypercholesterolemia were excluded, while heterozygous familial hypercholesterolemia was allowed.
04
Endpoints
Secondary
Total cholesterol change from baseline
High-density lipoprotein cholesterol change from baseline
Total cholesterol to HDL cholesterol ratio
Non-HDL to HDL cholesterol ratio
Triglycerides change from baseline
Apolipoprotein B change from baseline
Apolipoprotein A1 change from baseline
Apolipoprotein B to apolipoprotein A1 ratio
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