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OpenTrials
Completed

NCT Number: NCT00644709

A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Completion of base study
  • Dyslipidemia and at high risk of CHD

Exclusion criteria

  • Impaired liver function
  • Gastrointestinal disease that could limit drug absorption

Treatment and study plan

atorvastatin

Drug

Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.

Primary outcomes

  1. Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL

    Time frame: Week 52

Secondary outcomes

  1. Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly

    Time frame: Week 52

  2. LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels

    Time frame: Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study

  3. Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study

    Time frame: Baseline and Weeks 17, 34, and 52

  4. Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study

    Time frame: Week 52

  5. Adverse events and laboratory test changes

    Time frame: Weeks 17, 34, and 52

  6. Achievement of LDL-C target

    Time frame: Weeks 17 and 34

  7. Achievement of LDL-C target by diabetic patients

    Time frame: Week 52

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Multicenter, Open-Label Extension Study Of High-Risk Hyperlipidemic Patients Treated With An Atorvastatin Starting Dose Adapted To Their Baseline LDL-C Level

Important dates

Study start
2003
Study completion
2005
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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