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Completed

NCT Number: NCT00645424

A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol

The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol
  • Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of <400 mg/dL

Exclusion criteria

  • Type I diabetes mellitus
  • Secondary causes of high cholesterol
  • Elevated liver enzymes

Treatment and study plan

atorvastatin

Drug

Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks

Primary outcomes

  1. Percentage change in LDL-C levels from baseline to Week 12

    Time frame: Week 12

  2. Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12

    Time frame: Week 12

Secondary outcomes

  1. Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12

    Time frame: Weeks 4, 8, and 12

  2. Adverse events at Weeks 4, 8, and 12

    Time frame: Baseline and at Weeks 4, 8, and 12

  3. Clinical laboratory changes at Weeks 4, 8, and 12

    Time frame: Screening and at Weeks 4, 8, and 12

  4. Vital signs at Weeks 4, 8, and 12

    Time frame: Screening and at Weeks 4, 8, and 12

  5. Percentage change in LDL-C levels from baseline at Weeks 4 and 8

    Time frame: Weeks 4 and 8

  6. Percentage of LDL-C responders at Weeks 4 and 8

    Time frame: Weeks 4 and 8

  7. Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12

    Time frame: Weeks 4, 8, and 12

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia

Important dates

Study start
2003
Study completion
2004
First posted
Mar 27, 2008
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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