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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00644670

Enrollment

232

Registered

2008-03-27

Start date

2003-06-30

Completion date

2004-03-31

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias

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.

Interventions

DRUGAtorvastatin

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL	Week 12

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026