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Rosuvastatin ORBITAL Germany

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379249
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : March 26, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Rosuvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2002
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Cumulative direct/indirect disease-related costs were compared applying a societal perspective
  2. Costs include resource utilization for ambulatory, hospital, rehabilitative and nursing care, medication, physiotherapy, transportation, and productivity loss)

Secondary Outcome Measures :
  1. Achievement of the 1998 European LDL-C goal of <115 mg/dL (3.0 mmol/L)
  2. Changes in the lipid profile and compliance with therapy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • contra-indications for statin therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379249

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00379249    
Other Study ID Numbers: D3560L00001
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: March 26, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors