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

Dyslipidemias Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644670
• Other study ID #: A2581099
• Status: Completed
• Phase: Phase 4
• Start date: June 2003
• Est. completion date: March 2004

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Brasschaat
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Edegem
Belgium	Pfizer Investigational Site	Genk
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Gilly (charleroi)
Belgium	Pfizer Investigational Site	La Louvière
Belgium	Pfizer Investigational Site	Liège
Belgium	Pfizer Investigational Site	Mechelen
Belgium	Pfizer Investigational Site	Menen
Belgium	Pfizer Investigational Site	Merksem
Belgium	Pfizer Investigational Site	Mortsel
Belgium	Pfizer Investigational Site	Roeselare
Belgium	Pfizer Investigational Site	Seraing
Belgium	Pfizer Investigational Site	Wilrijk
Belgium	Pfizer Investigational Site	Wingene

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

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

External Links

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