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Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
This study has been completed.
First Received: August 30, 2005   Last Updated: October 28, 2008   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00141141
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
 Drug: Atorvastatin
Drug: Simvastatin
 Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol
Drug Information available for: Simvastatin Atorvastatin Atorvastatin calcium
U.S. FDA Resources

Further study details as provided by Pfizer:

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

Enrollment: 383
Study Start Date: January 2004
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141141

Locations
Italy
Pfizer Investigational Site
CAMPOBASSO, Italy, 86100
Pfizer Investigational Site
GENOVA, Italy, 16132
Pfizer Investigational Site
PERUGIA, Italy, 06100
Pfizer Investigational Site
PISA, Italy, 56124
Pfizer Investigational Site
ROMA, Italy, 00161
Pfizer Investigational Site
ANCONA, Italy, 60100
Pfizer Investigational Site
ASTI, Italy, 14100
Pfizer Investigational Site
ROMA, Italy, 00168
Pfizer Investigational Site
BARI, Italy, 70124
Pfizer Investigational Site
CATANZARO, Italy, 88100
Pfizer Investigational Site
UDINE, Italy, 33100
Pfizer Investigational Site
PALERMO, Italy, 90127
Pfizer Investigational Site
NAPOLI, Italy, 80100
Pfizer Investigational Site
RIMINI, Italy, 47900
Pfizer Investigational Site
CAGLIARI, Italy, 09134
Pfizer Investigational Site
MILANO, Italy, 20142
Pfizer Investigational Site
ROMA, Italy, 00155
Pfizer Investigational Site
MILANO, Italy, 20145
Pfizer Investigational Site
TORINO, Italy, 10154
Pfizer Investigational Site
MESSINA, Italy, 98158
Pfizer Investigational Site
NAPOLI, Italy, 80131
Pfizer Investigational Site
CATANIA, Italy, 95124
Pfizer Investigational Site
S. Benedetto del Tronto (AP), Italy, 63039
Pfizer Investigational Site
CATANIA, Italy, 95126
Pfizer Investigational Site
PARMA, Italy, 43100
Pfizer Investigational Site
Roma, Italy, 00161
Pfizer Investigational Site
POTENZA, Italy, 85100
Pfizer Investigational Site
Milano, Italy, 20157
Pfizer Investigational Site
Ferrara, Italy, 44100
Pfizer Investigational Site
Roma, Italy, 00163
Italy, Ascoli Piceno
Pfizer Investigational Site
S. BENEDETTO DEL TRONTO, Ascoli Piceno, Italy, 63039
Italy, Brindisi
Pfizer Investigational Site
S.Pietro Vernotico, Brindisi, Italy
Italy, LECCE
Pfizer Investigational Site
CASARANO, LECCE, Italy, 73043
Italy, PV
Pfizer Investigational Site
PAVIA, PV, Italy, 27100
Italy, TORINO
Pfizer Investigational Site
ORBASSANO, TORINO, Italy, 10043
Italy, VE
Pfizer Investigational Site
MESTRE, VE, Italy, 30174
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site
Link to ClinicalStudyResults.org Posting:  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: A2581053
Study First Received: August 30, 2005
Last Updated: October 28, 2008
ClinicalTrials.gov Identifier: NCT00141141     History of Changes
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010



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