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

NCT ID: NCT00141141

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

383 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atorvastatin

Intervention Type DRUG

Simvastatin

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

S. Benedetto DEL Tronto, Ascoli Piceno, Italy

Site Status

Pfizer Investigational Site

S.Pietro Vernotico, Brindisi, Italy

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Pfizer Investigational Site

Casarano, Lecce, Italy

Site Status

Pfizer Investigational Site

Pavia, PV, Italy

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Pfizer Investigational Site

Orbassano, Torino, Italy

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Pfizer Investigational Site

Mestre, VE, Italy

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Pfizer Investigational Site

Ancona, , Italy

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Pfizer Investigational Site

Asti, , Italy

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Pfizer Investigational Site

Bari, , Italy

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Pfizer Investigational Site

Cagliari, , Italy

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Pfizer Investigational Site

Campobasso, , Italy

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Pfizer Investigational Site

Catania, , Italy

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Pfizer Investigational Site

Catania, , Italy

Site Status

Pfizer Investigational Site

Catanzaro, , Italy

Site Status

Pfizer Investigational Site

Ferrara, , Italy

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Pfizer Investigational Site

Genova, , Italy

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Pfizer Investigational Site

Messina, , Italy

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Pfizer Investigational Site

Milan, , Italy

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Pfizer Investigational Site

Milan, , Italy

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Pfizer Investigational Site

Milan, , Italy

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Pfizer Investigational Site

Napoli, , Italy

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Pfizer Investigational Site

Napoli, , Italy

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Pfizer Investigational Site

Palermo, , Italy

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Pfizer Investigational Site

Parma, , Italy

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Pfizer Investigational Site

Perugia, , Italy

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Pfizer Investigational Site

Pisa, , Italy

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Pfizer Investigational Site

Potenza, , Italy

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Pfizer Investigational Site

Rimini, , Italy

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Pfizer Investigational Site

Roma, , Italy

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Pfizer Investigational Site

Roma, , Italy

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Pfizer Investigational Site

Roma, , Italy

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Pfizer Investigational Site

Roma, , Italy

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Pfizer Investigational Site

S. Benedetto Del Tronto (AP), , Italy

Site Status

Pfizer Investigational Site

Torino, , Italy

Site Status

Pfizer Investigational Site

Udine, , Italy

Site Status

Countries

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Italy

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581053&StudyName=Efficacy%20And%20Safety%20Study%20Of%20Atorvastatin%20Versus%20Simvastatin%20In%20Type%202%20Diabetic%20Subjects%20With%20Hypercholesterolemia

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

Other Identifiers

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A2581053

Identifier Type: -

Identifier Source: org_study_id

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