Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)

Hypercholesterolemia Clinical Trial

Official title:

Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396110
• Other study ID #: 25V06
• Secondary ID: TARGET
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2006
• Last updated: November 3, 2006
• Start date: February 2003

Study information

• Verified date: February 2003
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

In this study the effect of the switch to rosuvastatin from another statin (fluvastatin, pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET) representing daily practice. Primary end points analysis was the percentage of patients reaching the target of LDL-C < 3.2 mmol/l. Secondary outcomes were the changes of LDL-C, HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3889
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• High-risk patients with and without evident CHD who had LDL-C > 3.2 mmol/l and were treated at that moment with HMG-CoA-reductase inhibitor apart from rosuvastatin.

• Patients were aged >18 years and <70 years (men) and < 75 years (women).

Exclusion Criteria:

• Treatment with atorvastatin 40 or 80 mg or simvastatin 80 mg

• Patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases) and/or contra-indications for treatment with rosuvastatin

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Hypercholesterolemia
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca