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

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

Genetics Home Reference related topics:

hypercholesterolemia

MedlinePlus related topics:

Cholesterol

Drug Information available for:

Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)- Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

Study ID Numbers:	D3560L00008, ORBITAL
First Received:	November 3, 2006
Last Updated:	November 3, 2006
ClinicalTrials.gov Identifier:	NCT00396240
Health Authority:	Switzerland: Swissmedic

Keywords provided by AstraZeneca:

rosuvastatin

hypercholesterolaemia

cholesterol

LDL-C

triglyceride

plasma lipids

compliance

Study placed in the following topic categories:

Rosuvastatin

Metabolic Diseases

Hyperlipidemias

Metabolic disorder

Hypercholesterolemia

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2008

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