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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141141
First Posted: September 1, 2005
Last Update Posted: October 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141141


Locations
Italy
Pfizer Investigational Site
S. Benedetto Del Tronto, Ascoli Piceno, Italy, 63039
Pfizer Investigational Site
S.Pietro Vernotico, Brindisi, Italy
Pfizer Investigational Site
Casarano, Lecce, Italy, 73043
Pfizer Investigational Site
Pavia, PV, Italy, 27100
Pfizer Investigational Site
Orbassano, Torino, Italy, 10043
Pfizer Investigational Site
Mestre, VE, Italy, 30174
Pfizer Investigational Site
Ancona, Italy, 60100
Pfizer Investigational Site
Asti, Italy, 14100
Pfizer Investigational Site
Bari, Italy, 70124
Pfizer Investigational Site
Cagliari, Italy, 09134
Pfizer Investigational Site
Campobasso, Italy, 86100
Pfizer Investigational Site
Catania, Italy, 95124
Pfizer Investigational Site
Catania, Italy, 95126
Pfizer Investigational Site
Catanzaro, Italy, 88100
Pfizer Investigational Site
Ferrara, Italy, 44100
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Messina, Italy, 98158
Pfizer Investigational Site
Milano, Italy, 20142
Pfizer Investigational Site
Milano, Italy, 20145
Pfizer Investigational Site
Milano, Italy, 20157
Pfizer Investigational Site
Napoli, Italy, 80100
Pfizer Investigational Site
Napoli, Italy, 80131
Pfizer Investigational Site
Palermo, Italy, 90127
Pfizer Investigational Site
Parma, Italy, 43100
Pfizer Investigational Site
Perugia, Italy, 06100
Pfizer Investigational Site
Pisa, Italy, 56124
Pfizer Investigational Site
Potenza, Italy, 85100
Pfizer Investigational Site
Rimini, Italy, 47900
Pfizer Investigational Site
Roma, Italy, 00155
Pfizer Investigational Site
Roma, Italy, 00161
Pfizer Investigational Site
Roma, Italy, 00163
Pfizer Investigational Site
Roma, Italy, 00168
Pfizer Investigational Site
S. Benedetto del Tronto (AP), Italy, 63039
Pfizer Investigational Site
Torino, Italy, 10154
Pfizer Investigational Site
Udine, Italy, 33100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00141141     History of Changes
Other Study ID Numbers: A2581053
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: October 31, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors