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This study has been withdrawn prior to enrollment.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 )

First Received on November 3, 2006. Last Updated on March 25, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00396240

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396240

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Madeleine Billeter, MD	AstraZeneca
Principal Investigator:	W. Riesen, MD	Kantonsspital St. Gallen
Principal Investigator:	R. Darioli, MD	CHUV (Centre Hospitalier Universitaire Vaudois) Lausanne

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00396240 History of Changes
Other Study ID Numbers:	D3560L00008, ORBITAL
Study First Received:	November 3, 2006
Last Updated:	March 25, 2009
Health Authority:	Switzerland: Swissmedic

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
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 February 09, 2012