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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00396240
First Posted: November 6, 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
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: None (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
  Eligibility

Information from the National Library of Medicine

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

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.
  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): NCT00396240


Sponsors and Collaborators
AstraZeneca
Investigators
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

ClinicalTrials.gov Identifier: NCT00396240     History of Changes
Other Study ID Numbers: D3560L00008
ORBITAL
First Submitted: November 3, 2006
First Posted: November 6, 2006
Last Update Posted: March 26, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
rosuvastatin
hypercholesterolaemia
cholesterol
LDL-C
triglyceride
plasma lipids
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