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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.383 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

383

Conditions

Hypercholesterolemia

Interventions

AtorvastatinDRUG

SimvastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (35)

Outcomes

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

Data from ClinicalTrials.gov

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Pfizer Investigational Site

S. Benedetto DEL Tronto, Ascoli Piceno, Italy

Pfizer Investigational Site

S.Pietro Vernotico, Brindisi, Italy

Pfizer Investigational Site

Casarano, Lecce, Italy

Pfizer Investigational Site

Pavia, PV, Italy

Pfizer Investigational Site

Orbassano, Torino, Italy

Pfizer Investigational Site

Mestre, VE, Italy

Pfizer Investigational Site

Ancona, Italy

Pfizer Investigational Site

Asti, Italy

Pfizer Investigational Site

Bari, Italy

Pfizer Investigational Site

Cagliari, Italy

...and 25 more locations