Clinical trial NCT00644709: A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemias
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 196
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
timeFrame: Week 52
Secondary outcomes:
measure: Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly
timeFrame: Week 52
measure: LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels
timeFrame: Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study
measure: 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
timeFrame: Baseline and Weeks 17, 34, and 52
measure: Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study
timeFrame: Week 52
measure: Adverse events and laboratory test changes
timeFrame: Weeks 17, 34, and 52
measure: Achievement of LDL-C target
timeFrame: Weeks 17 and 34
measure: Achievement of LDL-C target by diabetic patients
timeFrame: Week 52
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Pfizer Investigational Site
city: Brasschaat
country: Belgium
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Gilly (charleroi)
country: Belgium
facility: Pfizer Investigational Site
city: La Louvière
country: Belgium
facility: Pfizer Investigational Site
city: Mechelen
country: Belgium
facility: Pfizer Investigational Site
city: Menen
country: Belgium
facility: Pfizer Investigational Site
city: Merksem
country: Belgium
facility: Pfizer Investigational Site
city: Mortsel
country: Belgium
facility: Pfizer Investigational Site
city: Roeselare
country: Belgium
facility: Pfizer Investigational Site
city: Seraing
country: Belgium
facility: Pfizer Investigational Site
city: Wilrijk
country: Belgium
facility: Pfizer Investigational Site
city: Wingene
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: