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A Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol

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ClinicalTrials.gov Identifier: NCT00644670
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 28, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step titration.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Twelve-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving LDL Cholesterol Targets With Atorvastatin Starting Doses Of 10 Mg, 20 Mg And 40 Mg.
Study Start Date : June 2003
Study Completion Date : March 2004


Arms and Interventions

Arm Intervention/treatment
Experimental: Previous Treatment with a Usual Maintenance Dose of a Statin Drug: Atorvastatin
In previously treated patients, starting atorvastatin doses (oral tablets given once daily) of 20 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline) or 40 mg (in patients with LDL-C levels between 165 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.
Experimental: Statin-Naive Drug: Atorvastatin
In statin-naive patients, starting atorvastatin doses (oral tablets given once daily) of 10 mg (in patients with LDL-C levels between 115 and 164 mg/dL at baseline), 20 mg (in patients with LDL-C levels between 165 and 174 mg/dL at baseline), or 40 mg (in patients with LDL-C levels between 175 and 235 mg/dL at baseline) were given for 6 weeks. If LDL-C target was achieved at Week 6, doses remained the same. If LDL-C target was not achieved at Week 6, doses were doubled.


Outcome Measures

Primary Outcome Measures :
  1. Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Mean percent change from baseline in LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, triglycerides, and apolipoprotein B for statin-naive patients [ Time Frame: Weeks 6 and 12 ]
  2. Proportion of subjects across different LDL-C strata who achieved LDL-C target [ Time Frame: Week 6 ]
  3. Proportion of diabetic subjects in entire group who achieved LDL-C target [ Time Frame: Week 12 ]
  4. Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL) [ Time Frame: Week 12 ]
  5. Change from baseline in hemoglobin A1c levels [ Time Frame: Week 12 ]
  6. Adverse events and laboratory test changes [ Time Frame: Weeks 6 and 12 ]
  7. Proportion of subjects in entire group who achieved LDL-C target [ Time Frame: Week 6 ]

Eligibility Criteria

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

Inclusion Criteria:

  • Dyslipidemia
  • At a high risk for coronary heart disease

Exclusion Criteria:

  • Use of higher than usual maintenance doses of statin drugs at screening
  • Uncontrolled diabetes or high blood pressure
  • Impaired liver function
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00644670


Locations
Belgium
Pfizer Investigational Site
Antwerpen, Belgium, 2018
Pfizer Investigational Site
Brasschaat, Belgium, 2930
Pfizer Investigational Site
Brussels, Belgium, 1180
Pfizer Investigational Site
Edegem, Belgium, 2650
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
Liège, Belgium, 4000
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644670     History of Changes
Other Study ID Numbers: A2581099
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

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