Rosuvastatin ORBITAL Germany

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379249
• Other study ID #: D3560L00001
• Secondary ID: ORBITAL
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2006
• Last updated: March 25, 2009
• Start date: February 2002
• Est. completion date: February 2004

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• contra-indications for statin therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative direct/indirect disease-related costs were compared applying a societal perspective
Primary	Costs include resource utilization for ambulatory, hospital, rehabilitative and nursing care, medication, physiotherapy, transportation, and productivity loss)
Secondary	Achievement of the 1998 European LDL-C goal of <115 mg/dL (3.0 mmol/L)
Secondary	Changes in the lipid profile and compliance with therapy.