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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644670
First received: March 24, 2008
Last updated: March 26, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Dyslipidemias
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects across different LDL-C strata who achieved LDL-C target [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Proportion of diabetic subjects in entire group who achieved LDL-C target [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in hemoglobin A1c levels [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Adverse events and laboratory test changes [ Time Frame: Weeks 6 and 12 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects in entire group who achieved LDL-C target [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Enrollment: 232
Study Start Date: June 2003
Study Completion Date: March 2004
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644670     History of Changes
Other Study ID Numbers: A2581099
Study First Received: March 24, 2008
Last Updated: March 26, 2008
Health Authority: Belgium: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014