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Rosuvastatin ORBITAL Germany
NCT00379249Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2002
- Sponsor
- AstraZeneca
- Modality
- Orthosteric Ligands
- Drugs
- rosuvastatin
- Conditions
- hypercholesterolemia
01
Overview
Phase 3, randomised, open-label trial of rosuvastatin in hypercholesterolemia (2 arms), sponsored by AstraZeneca. Primary endpoint: Cumulative direct and indirect disease-related costs at 36 months. Started Feb 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Rosuvastatin + Additional Care
Rosuvastatin treatment plus drug intake adherence and lifestyle enhancing initiatives.
Rosuvastatin Alone
Standard Rosuvastatin treatment.
03
Who it enrols
Patients with high cholesterol and an indication for statin treatment according to Joint European Guidelines.
04
Endpoints
Primary
Cumulative direct and indirect disease-related costs
Secondary
Achievement of the 1998 European LDL-C goal
Changes in the lipid profile
Compliance with therapy
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