Rosuvastatin ORBITAL Germany

Phase 3

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00379249
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study Completion: 2004-02
• Study First Submitted: 2006-09-20
• Study First Submitted QC: 2006-09-20
• Study First Posted: 2006-09-21
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-25
• Last Update Posted: 2009-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

• high cholesterol with an indication for cholesterol-lowering medication (statins)

Exclusion Criteria

• contra-indications for statin therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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.