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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141141
First received: August 30, 2005
Last updated: October 28, 2008
Last verified: October 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 95126
Pfizer Investigational Site
Catania, Italy, 95124
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, 00163
Pfizer Investigational Site
Roma, Italy, 00168
Pfizer Investigational Site
Roma, Italy, 00161
Pfizer Investigational Site
Roma, Italy, 00155
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:
No publications provided

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

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

ClinicalTrials.gov processed this record on September 16, 2014