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OpenTrials
Completed

NCT Number: NCT00141141

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, S. Benedetto DEL Tronto, Ascoli Piceno, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

atorvastatin

Drug

simvastatin

Drug

Primary outcomes

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

Secondary outcomes

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

  2. To evaluate safety of Atorvastatin vs Simvastatin

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2007
First posted
Sep 1, 2005
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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