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

Phase 4

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00141141
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Study Completion: 2007-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 383

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the decrease of LDL-C after 24 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
To evaluate the changes from baseline of targeted blood markers.
To evaluate safety of Atorvastatin vs Simvastatin

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇹 Udine, Italy