Clinical trial NCT00141141: Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: To evaluate the decrease of LDL-C after 24 weeks of treatment.
Secondary outcomes:
measure: To evaluate the changes from baseline of targeted blood markers.
measure: To evaluate safety of Atorvastatin vs Simvastatin
Other outcomes:
Locations:
city: S. Benedetto DEL Tronto
country: Italy
facility: Pfizer Investigational Site
state: Ascoli Piceno
city: S.Pietro Vernotico
country: Italy
facility: Pfizer Investigational Site
state: Brindisi
city: Casarano
country: Italy
facility: Pfizer Investigational Site
state: Lecce
city: Pavia
country: Italy
facility: Pfizer Investigational Site
state: PV
city: Orbassano
country: Italy
facility: Pfizer Investigational Site
state: Torino
city: Mestre
country: Italy
facility: Pfizer Investigational Site
state: VE
city: Ancona
country: Italy
facility: Pfizer Investigational Site
city: Asti
country: Italy
facility: Pfizer Investigational Site
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Cagliari
country: Italy
facility: Pfizer Investigational Site
city: Campobasso
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Catanzaro
country: Italy
facility: Pfizer Investigational Site
city: Ferrara
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Messina
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Parma
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Potenza
country: Italy
facility: Pfizer Investigational Site
city: Rimini
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: S. Benedetto Del Tronto (AP)
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: