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OpenTrials
Completed

NCT Number: NCT00379249

Rosuvastatin ORBITAL Germany

The primary objective of the study is to compare the effect of rosuvastatin therapy plus compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term cumulative direct and indirect disease-related costs during the 36 month.

Completed

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Key information

Conditions

Hypercholesterolemia Behavior Dyslipidemias Health Behavior Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • high cholesterol with an indication for cholesterol-lowering medication (statins)

Exclusion criteria

  • contra-indications for statin therapy

Treatment and study plan

Rosuvastatin

Drug

Primary outcomes

  1. Cumulative direct/indirect disease-related costs were compared applying a societal perspective

  2. Costs include resource utilization for ambulatory, hospital, rehabilitative and nursing care, medication, physiotherapy, transportation, and productivity loss)

Secondary outcomes

  1. Achievement of the 1998 European LDL-C goal of <115 mg/dL (3.0 mmol/L)

  2. Changes in the lipid profile and compliance with therapy.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Effects of a Twelve Months ROSUVASTATIN Treatment Plus Additional Care (Drug Intake Adherence and Lifestyle Enhancing Initiatives ) Compared to ROSUVASTATIN Treatment Alone on Long-Term Disease-Related Costs in Patients With an Indication for Statin Treatment According to the Joint European Guidelines

Important dates

Study start
2002
Study completion
2004
First posted
Sep 21, 2006
Registry last updated
Mar 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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