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This study has been withdrawn prior to enrollment.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:
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.
Procedure: Initiatives to improve compliance
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
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:
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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 ClinicalTrials.gov identifier: NCT00396240
||Madeleine Billeter, MD
||W. Riesen, MD
||Cantonal Hospital of St. Gallen
||R. Darioli, MD
||CHUV (Centre Hospitalier Universitaire Vaudois) Lausanne
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 3, 2006
||March 25, 2009
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Lipid Metabolism Disorders
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents