The study will investigate the effects of atorvastatin on the concentrations of small, dense LDL and HDL subfractions in patients with diabetes and the underlying mechanisms of these effects.
This study was terminated on October 6, 2004. The study terminated prematurely because of a higher screening failure rate than expected. There were no safety or efficacy reasons involved in the decision to terminate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
After a run-in phase of 4 weeks eligible patients were randomized at a ratio of 2 : 1 (atorvastatin : placebo). Patients in the atorvastatin group were treated with atorvastatin 20 mg tablets administered once daily orally for 8 weeks.
After a run-in phase of 4 weeks eligible patients were randomized at a ratio of 2 : 1 (atorvastatin : placebo). Patients in the placebo group were treated with placebo 20 mg tablets administered once daily orally for 8 weeks.
Pfizer Investigational Site
BAD Muenster AM Stein, Germany
Pfizer Investigational Site
Bosenheim, Germany
Pfizer Investigational Site
Bretten, Germany
Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
Changes in concentration of apolipoprotein B in VLDL, IDL, LDL-1 through LDL-6 and apolipoprotein A I in HDL subfractions 2a, 2b, and HDL-3 compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
Changes in size of LDL subfractions compared with screening (visit 1)
Time frame: 8 weeks (visit 4)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pfizer Investigational Site
Dresden, Germany
Pfizer Investigational Site
Duisburg, Germany
Pfizer Investigational Site
Essen, Germany
Pfizer Investigational Site
Goch, Germany
Pfizer Investigational Site
Heidelberg, Germany
Pfizer Investigational Site
Künzing, Germany
Pfizer Investigational Site
Offenbach, Germany
...and 4 more locations