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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644709
First received: March 25, 2008
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Dyslipidemias
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Adverse events and laboratory test changes [ Time Frame: Weeks 17, 34, and 52 ] [ Designated as safety issue: Yes ]
  • Achievement of LDL-C target [ Time Frame: Weeks 17 and 34 ] [ Designated as safety issue: No ]
  • Achievement of LDL-C target by diabetic patients [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: September 2003
Study Completion Date: March 2005
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644709

Locations
Belgium
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
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: NCT00644709     History of Changes
Other Study ID Numbers: A2581112
Study First Received: March 25, 2008
Last Updated: March 27, 2008
Health Authority: Belgium: Ministry of Health

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

ClinicalTrials.gov processed this record on April 16, 2014