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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Atorvastatin
Simvastatin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate the changes from baseline of targeted blood markers.
To evaluate safety of Atorvastatin vs Simvastatin

Full Information

First Posted
August 30, 2005
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00141141
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
383 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Primary Outcome Measure Information:
Title
To evaluate the decrease of LDL-C after 24 weeks of treatment.
Secondary Outcome Measure Information:
Title
To evaluate the changes from baseline of targeted blood markers.
Title
To evaluate safety of Atorvastatin vs Simvastatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
S. Benedetto DEL Tronto
State/Province
Ascoli Piceno
ZIP/Postal Code
63039
Country
Italy
Facility Name
Pfizer Investigational Site
City
S.Pietro Vernotico
State/Province
Brindisi
Country
Italy
Facility Name
Pfizer Investigational Site
City
Casarano
State/Province
Lecce
ZIP/Postal Code
73043
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Pfizer Investigational Site
City
Mestre
State/Province
VE
ZIP/Postal Code
30174
Country
Italy
Facility Name
Pfizer Investigational Site
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Asti
ZIP/Postal Code
14100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Cagliari
ZIP/Postal Code
09134
Country
Italy
Facility Name
Pfizer Investigational Site
City
Campobasso
ZIP/Postal Code
86100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Pfizer Investigational Site
City
Messina
ZIP/Postal Code
98158
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20145
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
ZIP/Postal Code
80100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Pfizer Investigational Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Pfizer Investigational Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Perugia
ZIP/Postal Code
06100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00155
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00163
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Pfizer Investigational Site
City
S. Benedetto Del Tronto (AP)
ZIP/Postal Code
63039
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10154
Country
Italy
Facility Name
Pfizer Investigational Site
City
Udine
ZIP/Postal Code
33100
Country
Italy

12. IPD Sharing Statement

Links:
URL
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
Description
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Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia

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