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

Primary Hypercholesterolaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00396240
• Other study ID #: D3560L00008
• Secondary ID: ORBITAL
• Status: Withdrawn
• Phase: Phase 4
• First received: November 3, 2006
• Last updated: March 25, 2009
• Start date: February 2002

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 1294
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolaemia

Intervention

Drug:
• Rosuvastatin

Procedure:
• Initiatives to improve compliance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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,
Secondary	Safety of treatment.