Back to resultsRosuvastatin ORBITAL Germany
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring hypercholesterolemia, statin, compliance
Eligibility Criteria
Inclusion Criteria:
- high cholesterol with an indication for cholesterol-lowering medication (statins)
Exclusion Criteria:
- contra-indications for statin therapy
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00379249
Brief Title
Rosuvastatin ORBITAL Germany
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
hypercholesterolemia, statin, compliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Primary Outcome Measure Information:
Title
Cumulative direct/indirect disease-related costs were compared applying a societal perspective
Title
Costs include resource utilization for ambulatory, hospital, rehabilitative and nursing care, medication, physiotherapy, transportation, and productivity loss)
Secondary Outcome Measure Information:
Title
Achievement of the 1998 European LDL-C goal of <115 mg/dL (3.0 mmol/L)
Title
Changes in the lipid profile and compliance with therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
high cholesterol with an indication for cholesterol-lowering medication (statins)
Exclusion Criteria:
contra-indications for statin therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Meyer - Sabellek, MD
Organizational Affiliation
AstraZeneca Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stefan Stefan Willich, MD
Organizational Affiliation
Charité Berlin, Germany
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26051201
Citation
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.
Results Reference
derived
PubMed Identifier
24671104
Citation
Muller-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.
Results Reference
derived
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Rosuvastatin ORBITAL Germany
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