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

March 25, 2009 updated by: AstraZeneca
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1294

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Registration Dates

First Submitted

November 3, 2006

First Submitted That Met QC Criteria

November 3, 2006

First Posted (Estimate)

November 6, 2006

Study Record Updates

Last Update Posted (Estimate)

March 26, 2009

Last Update Submitted That Met QC Criteria

March 25, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3560L00008
  • Orbital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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