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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00141141
• Collaborator: (none)
• Enrollment: 383
• Locations: 35
• Duration (Months): 39
• Patients Per Site: 10.9
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: Atorvastatin; Drug: Simvastatin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 383 participants
• 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
• Study Start Date: Jan 1, 2004
• Actual Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. To evaluate the changes from baseline of targeted blood markers. []

2. To evaluate safety of Atorvastatin vs Simvastatin []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	S. Benedetto DEL Tronto	Ascoli Piceno	Italy	63039
2	Pfizer Investigational Site	S.Pietro Vernotico	Brindisi	Italy
3	Pfizer Investigational Site	Casarano	Lecce	Italy	73043
4	Pfizer Investigational Site	Pavia	PV	Italy	27100
5	Pfizer Investigational Site	Orbassano	Torino	Italy	10043
6	Pfizer Investigational Site	Mestre	VE	Italy	30174
7	Pfizer Investigational Site	Ancona		Italy	60100
8	Pfizer Investigational Site	Asti		Italy	14100
9	Pfizer Investigational Site	Bari		Italy	70124
10	Pfizer Investigational Site	Cagliari		Italy	09134
11	Pfizer Investigational Site	Campobasso		Italy	86100
12	Pfizer Investigational Site	Catania		Italy	95124
13	Pfizer Investigational Site	Catania		Italy	95126
14	Pfizer Investigational Site	Catanzaro		Italy	88100
15	Pfizer Investigational Site	Ferrara		Italy	44100
16	Pfizer Investigational Site	Genova		Italy	16132
17	Pfizer Investigational Site	Messina		Italy	98158
18	Pfizer Investigational Site	Milano		Italy	20142
19	Pfizer Investigational Site	Milano		Italy	20145
20	Pfizer Investigational Site	Milano		Italy	20157
21	Pfizer Investigational Site	Napoli		Italy	80100
22	Pfizer Investigational Site	Napoli		Italy	80131
23	Pfizer Investigational Site	Palermo		Italy	90127
24	Pfizer Investigational Site	Parma		Italy	43100
25	Pfizer Investigational Site	Perugia		Italy	06100
26	Pfizer Investigational Site	Pisa		Italy	56124
27	Pfizer Investigational Site	Potenza		Italy	85100
28	Pfizer Investigational Site	Rimini		Italy	47900
29	Pfizer Investigational Site	Roma		Italy	00155
30	Pfizer Investigational Site	Roma		Italy	00161
31	Pfizer Investigational Site	Roma		Italy	00163
32	Pfizer Investigational Site	Roma		Italy	00168
33	Pfizer Investigational Site	S. Benedetto Del Tronto (AP)		Italy	63039
34	Pfizer Investigational Site	Torino		Italy	10154
35	Pfizer Investigational Site	Udine		Italy	33100

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00141141
• Other Study ID Numbers: A2581053
• First Posted: Sep 1, 2005
• Last Update Posted: Feb 18, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Hypercholesterolemia; Atorvastatin; Simvastatin

Study Results

No Results Posted as of Feb 18, 2021