Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
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
1 other identifier
interventional
383
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2004
Typical duration for phase_4
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedFebruary 18, 2021
February 1, 2021
August 30, 2005
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the decrease of LDL-C after 24 weeks of treatment.
Secondary Outcomes (2)
To evaluate the changes from baseline of targeted blood markers.
To evaluate safety of Atorvastatin vs Simvastatin
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of type 2 diabetes mellitus
- LDL-C \> 130 mg/dL
You may not qualify if:
- Insulin therapy
- Clinically relevant organ disease (creatininemia \>2mg/dL, CHF NYHA III and IV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Pfizer Investigational Site
S. Benedetto DEL Tronto, Ascoli Piceno, 63039, Italy
Pfizer Investigational Site
S.Pietro Vernotico, Brindisi, Italy
Pfizer Investigational Site
Casarano, Lecce, 73043, Italy
Pfizer Investigational Site
Pavia, PV, 27100, Italy
Pfizer Investigational Site
Orbassano, Torino, 10043, Italy
Pfizer Investigational Site
Mestre, VE, 30174, Italy
Pfizer Investigational Site
Ancona, 60100, Italy
Pfizer Investigational Site
Asti, 14100, Italy
Pfizer Investigational Site
Bari, 70124, Italy
Pfizer Investigational Site
Cagliari, 09134, Italy
Pfizer Investigational Site
Campobasso, 86100, Italy
Pfizer Investigational Site
Catania, 95124, Italy
Pfizer Investigational Site
Catania, 95126, Italy
Pfizer Investigational Site
Catanzaro, 88100, Italy
Pfizer Investigational Site
Ferrara, 44100, Italy
Pfizer Investigational Site
Genova, 16132, Italy
Pfizer Investigational Site
Messina, 98158, Italy
Pfizer Investigational Site
Milan, 20142, Italy
Pfizer Investigational Site
Milan, 20145, Italy
Pfizer Investigational Site
Milan, 20157, Italy
Pfizer Investigational Site
Napoli, 80100, Italy
Pfizer Investigational Site
Napoli, 80131, Italy
Pfizer Investigational Site
Palermo, 90127, Italy
Pfizer Investigational Site
Parma, 43100, Italy
Pfizer Investigational Site
Perugia, 06100, Italy
Pfizer Investigational Site
Pisa, 56124, Italy
Pfizer Investigational Site
Potenza, 85100, Italy
Pfizer Investigational Site
Rimini, 47900, Italy
Pfizer Investigational Site
Roma, 00155, Italy
Pfizer Investigational Site
Roma, 00161, Italy
Pfizer Investigational Site
Roma, 00163, Italy
Pfizer Investigational Site
Roma, 00168, Italy
Pfizer Investigational Site
S. Benedetto Del Tronto (AP), 63039, Italy
Pfizer Investigational Site
Torino, 10154, Italy
Pfizer Investigational Site
Udine, 33100, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
January 1, 2004
Study Completion
April 1, 2007
Last Updated
February 18, 2021
Record last verified: 2021-02