Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia

Condition(s) targeted: Hypercholesterolemia

Intervention: Atorvastatin (Drug); Simvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Official title: A Phase IV, Multicenter, Randomized, Open Label Study To Evaluate The Efficacy And Safety Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To evaluate the decrease of LDL-C after 24 weeks of treatment.

Secondary outcome:

To evaluate the changes from baseline of targeted blood markers.

To evaluate safety of Atorvastatin vs Simvastatin

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Diagnosis of type 2 diabetes mellitus LDL-C > 130 mg/dL Exclusion Criteria: Insulin therapy Clinically relevant organ disease (creatininemia >2mg/dL, CHF NYHA III and IV)

Pfizer Investigational Site, CAMPOBASSO 86100, Italy

Pfizer Investigational Site, GENOVA 16132, Italy

Pfizer Investigational Site, PERUGIA 06100, Italy

Pfizer Investigational Site, PISA 56124, Italy

Pfizer Investigational Site, ROMA 00161, Italy

Pfizer Investigational Site, ANCONA 60100, Italy

Pfizer Investigational Site, ASTI 14100, Italy

Pfizer Investigational Site, ROMA 00168, Italy

Pfizer Investigational Site, BARI 70124, Italy

Pfizer Investigational Site, MILANO 20145, Italy

Pfizer Investigational Site, UDINE 33100, Italy

Pfizer Investigational Site, PALERMO 90127, Italy

Pfizer Investigational Site, NAPOLI 80100, Italy

Pfizer Investigational Site, RIMINI 47900, Italy

Pfizer Investigational Site, CAGLIARI 09134, Italy

Pfizer Investigational Site, MILANO 20142, Italy

Pfizer Investigational Site, ROMA 00155, Italy

Pfizer Investigational Site, CATANZARO 88100, Italy

Pfizer Investigational Site, TORINO 10154, Italy

Pfizer Investigational Site, MESSINA 98158, Italy

Pfizer Investigational Site, NAPOLI 80131, Italy

Pfizer Investigational Site, CATANIA 95124, Italy

Pfizer Investigational Site, S. Benedetto del Tronto (AP) 63039, Italy

Pfizer Investigational Site, POTENZA 85100, Italy

Pfizer Investigational Site, PARMA 43100, Italy

Pfizer Investigational Site, Roma 00161, Italy

Pfizer Investigational Site, CATANIA 95126, Italy

Pfizer Investigational Site, Milano 20157, Italy

Pfizer Investigational Site, Ferrara 44100, Italy

Pfizer Investigational Site, Roma 00163, Italy

Pfizer Investigational Site, S. BENEDETTO DEL TRONTO, Ascoli Piceno 63039, Italy

Pfizer Investigational Site, S.Pietro Vernotico, Brindisi, Italy

Pfizer Investigational Site, CASARANO, LECCE 73043, Italy

Pfizer Investigational Site, PAVIA, PV 27100, Italy

Pfizer Investigational Site, ORBASSANO, TORINO 10043, Italy

Pfizer Investigational Site, MESTRE, VE 30174, Italy

To obtain contact information for a study center near you, click here.

Starting date: January 2004
Ending date: April 2007
Last updated: August 6, 2007