Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Rosuvastatin ORBITAL Germany

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00379249
First received: September 20, 2006
Last updated: March 25, 2009
Last verified: March 2009

September 20, 2006
March 25, 2009
February 2002
Not Provided
  • 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)
Same as current
Complete list of historical versions of study NCT00379249 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypercholesterolemia
Drug: Rosuvastatin
Not Provided
Müller-Nordhorn J, Muckelbauer R, Englert H, Grittner U, Berger H, Sonntag F, Völler 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8000
February 2004
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • contra-indications for statin therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00379249
D3560L00001, ORBITAL
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Wolfgang Meyer - Sabellek, MD AstraZeneca Germany
Principal Investigator: Stefan Stefan Willich, MD Charité Berlin, Germany
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP