Rosuvastatin ORBITAL Germany
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Rosuvastatin (Drug)
Phase: Phase 3
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
Wolfgang Meyer - Sabellek, MD, Study Director, Affiliation: AstraZeneca Germany
Stefan Stefan Willich, MD, Principal Investigator, Affiliation: Charité Berlin, Germany
The primary objective of the study is to compare the effect of rosuvastatin therapy plus
compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term
cumulative direct and indirect disease-related costs during the 36 month.
Official title: Effects of a Twelve Months ROSUVASTATIN Treatment Plus Additional Care (Drug Intake Adherence and Lifestyle Enhancing Initiatives ) Compared to ROSUVASTATIN Treatment Alone on Long-Term Disease-Related Costs in Patients With an Indication for Statin Treatment According to the Joint European Guidelines
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Cumulative direct/indirect disease-related costs were compared applying a societal perspective
Costs include resource utilization for ambulatory, hospital, rehabilitative and nursing care, medication, physiotherapy, transportation, and productivity loss)
Achievement of the 1998 European LDL-C goal of <115 mg/dL (3.0 mmol/L)
Changes in the lipid profile and compliance with therapy.
Minimum age: 18 Years.
Maximum age: N/A.
- high cholesterol with an indication for cholesterol-lowering medication (statins)
- contra-indications for statin therapy
Locations and Contacts
Starting date: February 2002
Last updated: September 20, 2006