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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00396240
First received: November 3, 2006
Last updated: March 25, 2009
Last verified: March 2009
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Cantonal Hospital of 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 August 26, 2014