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

A Multicenter, Open-Label Extension Study Of High-Risk Hyperlipidemic Patients Treated With An Atorvastatin Starting Dose Adapted To Their Baseline LDL-C Level

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00644709

Enrollment

196

Registered

2008-03-27

Start date

2003-09-30

Completion date

2005-03-31

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

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

Interventions

DRUGAtorvastatin

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL	Week 52

Secondary

Measure	Time frame
LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels	Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study
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	Baseline and Weeks 17, 34, and 52
Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study	Week 52
Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly	Week 52
Achievement of LDL-C target	Weeks 17 and 34
Achievement of LDL-C target by diabetic patients	Week 52
Adverse events and laboratory test changes	Weeks 17, 34, and 52

Countries

Belgium

Outcome results

None listed

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