Rosuvastatin ORBITAL Germany
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
2 other identifiers
interventional
8,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2002
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 20, 2006
CompletedFirst Posted
Study publicly available on registry
September 21, 2006
CompletedMarch 26, 2009
March 1, 2009
September 20, 2006
March 25, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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.
Interventions
Eligibility Criteria
You may qualify if:
- high cholesterol with an indication for cholesterol-lowering medication (statins)
You may not qualify if:
- contra-indications for statin therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Related Publications (2)
Muckelbauer R, Englert H, Rieckmann N, Chen CM, Wegscheider K, Voller H, Katus HA, Willich SN, Muller-Nordhorn J. Long-term effect of a low-intensity smoking intervention embedded in an adherence program for patients with hypercholesterolemia: Randomized controlled trial. Prev Med. 2015 Aug;77:155-61. doi: 10.1016/j.ypmed.2015.05.026. Epub 2015 Jun 4.
PMID: 26051201DERIVEDMuller-Nordhorn J, Muckelbauer R, Englert H, Grittner U, Berger H, Sonntag F, Voller H, Prugger C, Wegscheider K, Katus HA, Willich SN. Longitudinal association between body mass index and health-related quality of life. PLoS One. 2014 Mar 26;9(3):e93071. doi: 10.1371/journal.pone.0093071. eCollection 2014.
PMID: 24671104DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wolfgang Meyer - Sabellek, MD
AstraZeneca Germany
- PRINCIPAL INVESTIGATOR
Stefan Stefan Willich, MD
Charité Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 20, 2006
First Posted
September 21, 2006
Study Start
February 1, 2002
Study Completion
February 1, 2004
Last Updated
March 26, 2009
Record last verified: 2009-03