NCT00396240

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,294

participants targeted

Target at P75+ for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2006

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

First QC Date

November 3, 2006

Last Update Submit

March 25, 2009

Conditions

Primary Hypercholesterolaemia

Keywords

rosuvastatinhypercholesterolaemiacholesterolLDL-Ctriglycerideplasma lipidscompliance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

Interventions

RosuvastatinDRUG
Initiatives to improve compliancePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypercholesterolemiaPatient Compliance

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Madeleine Billeter, MD

    AstraZeneca

    STUDY DIRECTOR

  • W. Riesen, MD

    Cantonal Hospital of St. Gallen

    PRINCIPAL INVESTIGATOR

  • R. Darioli, MD

    CHUV (Centre Hospitalier Universitaire Vaudois) Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 3, 2006

First Posted

November 6, 2006

Study Start

February 1, 2002

Last Updated

March 26, 2009

Record last verified: 2009-03