The purpose of this study is to evaluate the efficacy of Atorvastatin vs Simvastatin in decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment phase.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Atorvastatin  Drug: Simvastatin	Phase IV

Further Study Details: 

Primary Outcomes: To evaluate the decrease of LDL-C after 24 weeks of treatment.
Secondary Outcomes: To evaluate the changes from baseline of targeted blood markers. To evaluate safety of Atorvastatin vs Simvastatin
Expected Total Enrollment:  600

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of type 2 diabetes mellitus
• LDL-C > 130 mg/dL  

Exclusion Criteria:

• Insulin therapy
• Clinically relevant organ disease (creatinemia >2mg/dL, CHF NYHA III and IV)

Please refer to this study by ClinicalTrials.gov identifier  NCT00141141

Pfizer CT.gov Call Center      1-800-718-1021 

Italy
      Pfizer Investigational Site, Campobasso,  86100,  Italy; Recruiting
      Pfizer Investigational Site, Campobasso,  86100,  Italy; Recruiting
      Pfizer Investigational Site, Genova,  16132,  Italy; Recruiting
      Pfizer Investigational Site, Perugia,  06100,  Italy; Recruiting
      Pfizer Investigational Site, Pisa,  56124,  Italy; Recruiting
      Pfizer Investigational Site, Roma,  00161,  Italy; Recruiting
      Pfizer Investigational Site, Ancona,  60100,  Italy; Recruiting
      Pfizer Investigational Site, Palermo,  90127,  Italy; No longer recruiting
      Pfizer Investigational Site, Asti,  14100,  Italy; Recruiting
      Pfizer Investigational Site, Roma,  00168,  Italy; Recruiting
      Pfizer Investigational Site, Bari,  70124,  Italy; Recruiting
      Pfizer Investigational Site, Milano,  20145,  Italy; Recruiting
      Pfizer Investigational Site, Milano,  20132,  Italy; No longer recruiting
      Pfizer Investigational Site, Udine,  33100,  Italy; Recruiting
      Pfizer Investigational Site, Palermo,  90127,  Italy; Recruiting
      Pfizer Investigational Site, Napoli,  80100,  Italy; Recruiting
      Pfizer Investigational Site, Rimini,  47900,  Italy; Recruiting
      Pfizer Investigational Site, Cagliari,  09134,  Italy; Recruiting
      Pfizer Investigational Site, Milano,  20142,  Italy; Recruiting
      Pfizer Investigational Site, Roma,  00155,  Italy; Recruiting
      Pfizer Investigational Site, Catanzaro,  88100,  Italy; Recruiting
      Pfizer Investigational Site, Torino,  10154,  Italy; Recruiting
      Pfizer Investigational Site, Messina,  98158,  Italy; Recruiting
      Pfizer Investigational Site, Napoli,  80131,  Italy; Recruiting
      Pfizer Investigational Site, Catania,  95124,  Italy; Recruiting
      Pfizer Investigational Site, Potenza,  85100,  Italy; Recruiting
      Pfizer Investigational Site, Parma,  43100,  Italy; Recruiting
      Pfizer Investigational Site, Catania,  95126,  Italy; Recruiting
      Pfizer Investigational Site, Milano,  20157,  Italy; Recruiting
      Pfizer Investigational Site, Ferrara,  44100,  Italy; Recruiting
      Pfizer Investigational Site, Ferrara,  44100,  Italy; Recruiting
Italy, 00161
      Pfizer Investigational Site, Roma,  00161,  Italy; Recruiting
Italy, Ascoli Piceno
      Pfizer Investigational Site, S. BENEDETTO DEL TRONTO,  Ascoli Piceno,  63039,  Italy; Recruiting
Italy, Brindisi
      Pfizer Investigational Site, S.Pietro Vernotico,  Brindisi,  Italy; Recruiting
Italy, LECCE
      Pfizer Investigational Site, Casarano,  LECCE,  73043,  Italy; Recruiting
Italy, PV
      Pfizer Investigational Site, Pavia,  PV,  27100,  Italy; Recruiting
Italy, TORINO
      Pfizer Investigational Site, Orbassano,  TORINO,  10043,  Italy; Recruiting
Italy, VE
      Pfizer Investigational Site, Mestre,  VE,  30174,  Italy; No longer recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A2581053
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141141
Health Authority: Italy: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-06