Back to resultsORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
Primary Purpose
Primary Hypercholesterolaemia
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rosuvastatin
Initiatives to improve compliance
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolaemia focused on measuring rosuvastatin, hypercholesterolaemia, cholesterol, LDL-C, triglyceride, plasma lipids, compliance
Eligibility 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.
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00396240
Brief Title
ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
Official Title
ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Withdrawn
Why Stopped
study cancelled prior to FSI
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolaemia
Keywords
rosuvastatin, hypercholesterolaemia, cholesterol, LDL-C, triglyceride, plasma lipids, compliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1294 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Type
Procedure
Intervention Name(s)
Initiatives to improve compliance
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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,
Title
Safety of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeleine Billeter, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
W. Riesen, MD
Organizational Affiliation
Cantonal Hospital of St. Gallen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R. Darioli, MD
Organizational Affiliation
CHUV (Centre Hospitalier Universitaire Vaudois) Lausanne
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
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