Rosuvastatin ORBITAL Germany

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 20, 2006
Last updated: March 25, 2009
Last verified: March 2009

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.

Condition Intervention Phase
Drug: Rosuvastatin
Phase 3

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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 8000
Study Start Date: February 2002
Study Completion Date: February 2004

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • contra-indications for statin therapy
  Contacts and Locations
Please refer to this study by its identifier: NCT00379249

Sponsors and Collaborators
Study Director: Wolfgang Meyer - Sabellek, MD AstraZeneca Germany
Principal Investigator: Stefan Stefan Willich, MD Charité Berlin, Germany
  More Information

No publications provided Identifier: NCT00379249     History of Changes
Other Study ID Numbers: D3560L00001, ORBITAL
Study First Received: September 20, 2006
Last Updated: March 25, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses processed this record on April 16, 2014