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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
History of Changes
  Purpose

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
Hypercholesterolemia
 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:

MedlinePlus related topics: Cholesterol Statins
U.S. FDA Resources

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
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00379249

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

No publications provided

ClinicalTrials.gov 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:
hypercholesterolemia
statin
compliance

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013