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ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals

This study has been withdrawn prior to enrollment.
(study cancelled prior to FSI)
Information provided by:
AstraZeneca Identifier:
First received: November 3, 2006
Last updated: March 25, 2009
Last verified: March 2009
24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.

Condition Intervention Phase
Primary Hypercholesterolaemia
Drug: Rosuvastatin
Procedure: Initiatives to improve compliance
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Comparison of the rosuvastatin therapy (10mg daily, titrated to 20mg at 12 weeks if necessary), alone or in combination with enhanced compliance initiatives, at 6 months, in bringing subjects with prim. hypercholesterolaemia to the EAS LDL-C target goals

Secondary Outcome Measures:
  • To investigate the effect of rosuvastatin, both with and without compliance initiatives on number and percentage of subjects within the EAS or local LDL-C and TC target goals after 12 week therapy,
  • Safety of treatment.

Estimated Enrollment: 1294
Study Start Date: February 2002

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

Inclusion Criteria:

  • Primary hypercholesterolaemia:
  • Statin naïve subjects (LDL-C level > 3.5 mmol/L) or subjects on an ineffective "start dose" of a lipid-lowering therapy (LDL-C level > 3.1 mmol/L).
  • CV risk > 20%,
  • history of CHD or other established atherosclerotic disease

Exclusion Criteria:

  • History of severe adverse events with another HMG-CoA reductase inhibitor
  • Secondary hypercholesterolaemia;
  • Unstable cardiovascular disease;
  • Uncontrolled diabetes, active liver disease;
  • Severe hepatic or renal impairment;
  • Treatment with cyclosporin.
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Please refer to this study by its identifier: NCT00396240

Sponsors and Collaborators
Study Director: Madeleine Billeter, MD AstraZeneca
Principal Investigator: W. Riesen, MD Cantonal Hospital of St. Gallen
Principal Investigator: R. Darioli, MD CHUV (Centre Hospitalier Universitaire Vaudois) Lausanne
  More Information Identifier: NCT00396240     History of Changes
Other Study ID Numbers: D3560L00008
Study First Received: November 3, 2006
Last Updated: March 25, 2009

Keywords provided by AstraZeneca:
plasma lipids

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on April 28, 2017