We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rosuvastatin ORBITAL Germany

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00379249
First Posted: September 21, 2006
Last Update Posted: March 26, 2009
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.
Information provided by:
AstraZeneca
  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
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

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
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00379249     History of Changes
Other Study ID Numbers: D3560L00001
ORBITAL
First Submitted: September 20, 2006
First Posted: September 21, 2006
Last Update Posted: March 26, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
hypercholesterolemia
statin
compliance

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