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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00644709
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 28, 2008
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: Atorvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2003
Actual Study Completion Date : March 2005

Arm Intervention/treatment
Experimental: Arm A Drug: Atorvastatin
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 Outcome Measures :
  1. Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00644709

Pfizer Investigational Site
Antwerpen, Belgium, 2018
Pfizer Investigational Site
Brasschaat, Belgium, 2930
Pfizer Investigational Site
Brussels, Belgium, 1180
Pfizer Investigational Site
Genk, Belgium, B-3600
Pfizer Investigational Site
Gent, Belgium, 9000
Pfizer Investigational Site
Gilly (charleroi), Belgium, 6060
Pfizer Investigational Site
La Louvière, Belgium, 7100
Pfizer Investigational Site
Mechelen, Belgium, 2800
Pfizer Investigational Site
Menen, Belgium, 8930
Pfizer Investigational Site
Merksem, Belgium, 2170
Pfizer Investigational Site
Mortsel, Belgium, 2640
Pfizer Investigational Site
Roeselare, Belgium, 8800
Pfizer Investigational Site
Seraing, Belgium, 4100
Pfizer Investigational Site
Wilrijk, Belgium, 2610
Pfizer Investigational Site
Wingene, Belgium, 8750
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00644709     History of Changes
Other Study ID Numbers: A2581112
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors