Clinical trial NCT00644670: A Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemias
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 232
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
timeFrame: Week 12
Secondary outcomes:
measure: 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
timeFrame: Weeks 6 and 12
measure: Proportion of subjects across different LDL-C strata who achieved LDL-C target
timeFrame: Week 6
measure: Proportion of diabetic subjects in entire group who achieved LDL-C target
timeFrame: Week 12
measure: Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL)
timeFrame: Week 12
measure: Change from baseline in hemoglobin A1c levels
timeFrame: Week 12
measure: Adverse events and laboratory test changes
timeFrame: Weeks 6 and 12
measure: Proportion of subjects in entire group who achieved LDL-C target
timeFrame: Week 6
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: Edegem
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: Liège
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: