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

Dyslipidemias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644709
• Other study ID #: A2581112
• Status: Completed
• Phase: Phase 4
• Start date: September 2003
• Est. completion date: March 2005

Study information

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

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• Atorvastatin
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.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Brasschaat
Belgium	Pfizer Investigational Site	Brussels
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	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	Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL		Week 52
Secondary	Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly		Week 52
Secondary	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
Secondary	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
Secondary	Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study		Week 52
Secondary	Adverse events and laboratory test changes		Weeks 17, 34, and 52
Secondary	Achievement of LDL-C target		Weeks 17 and 34
Secondary	Achievement of LDL-C target by diabetic patients		Week 52

External Links

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