Study Stopped
Study cancelled prior to FSI
Effect of an Internet Based Compliance Enhancement Tool in Subjects With Hypercholesterolemia
Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement of LDL Goals. - Denmark
2 other identifiers
interventional
1,175
1 country
109
Brief Summary
The purpose of the study is to determine whether an Internet based compliance tool is superior to common diet counselling in patients with hypercholesterolemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 16, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedMarch 26, 2009
March 1, 2009
October 16, 2005
March 25, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the number and percentage of subjects from each group (rosuvastatin or rosuvastatin + a compliance enhancement tool) who reached the DSAM LDL-C target goal (LDL-C < 3.0 mmol/L) after 6 months therapy (24 weeks).
Secondary Outcomes (6)
Number and percentage of subjects within the DSAM LDL-C target goal after 3 months therapy
Compliance with study drug assessed by tablet count data
Number and percentage of subjects increasing rosuvastatin dosage from 10 mg to 20 mg at week 12
Percentage change in TC, HDL-C, LDL-C, TG from week 0 to week 24
Change in weight after 6 months therapy
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Available personal mailbox and access to the Internet
- Primary hypercholesterolemia with CV risk \> 20% over 10 years judged by the investigator or a history of ischemic heart disease or other established atherosclerotic disease (claudicatio intermittens, apoplexia cerebri (ischaemic stroke)) or stable diabetes mellitus
- Fasting LDL-C level \> 3.2 mmol/L
You may not qualify if:
- Known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- Documented secondary hypercholesterolemia of any cause except stable diabetes mellitus (type 1 or type 2)
- History of serious adverse effect or hypersensitivity reactions to statins, in particular any history of myopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (109)
Research Site
Aabenraa, Denmark
Research Site
Aalborg, Denmark
Research Site
Aarhus C, Denmark
Research Site
Aerup, Denmark
Research Site
Albertslund, Denmark
Research Site
Ans, Denmark
Research Site
Ålbæk, Denmark
Research Site
Ålestrup, Denmark
Research Site
Bagsværd, Denmark
Research Site
Billund, Denmark
Research Site
Birkeroed, Denmark
Research Site
Broendby Strand, Denmark
Research Site
Broenshoej, Denmark
Research Site
Copenhagen V, Denmark
Research Site
Elsingore, Denmark
Research Site
Farum, Denmark
Research Site
Fredericia, Denmark
Research Site
Frederiksberg C, Denmark
Research Site
Frederikshavn, Denmark
Research Site
Frederikssund, Denmark
Research Site
Gentofte Municipality, Denmark
Research Site
Glesborg, Denmark
Research Site
Glostrup Municipality, Denmark
Research Site
Goerlev Sjaelland, Denmark
Research Site
Grenå, Denmark
Research Site
Greve, Denmark
Research Site
Grindsted, Denmark
Research Site
Hadsund, Denmark
Research Site
Haslev, Denmark
Research Site
Hårlev, Denmark
Research Site
Hedehusene, Denmark
Research Site
Hellerup, Denmark
Research Site
Helsinge, Denmark
Research Site
Herning, Denmark
Research Site
Hilleroed, Denmark
Research Site
Hoeng, Denmark
Research Site
Hoersholm, Denmark
Research Site
Holbæk, Denmark
Research Site
Hornbæk, Denmark
Research Site
Horsens, Denmark
Research Site
Humlebæk, Denmark
Research Site
Hvidovre, Denmark
Research Site
Ikast, Denmark
Research Site
Jægerspris, Denmark
Research Site
Kalundborg, Denmark
Research Site
Karlslunde, Denmark
Research Site
Kåstrup, Denmark
Research Site
Kjellerup, Denmark
Research Site
Kokkedal, Denmark
Research Site
Kolding, Denmark
Research Site
Kongens Lyngby, Denmark
Research Site
Kværndrup, Denmark
Research Site
Langeskov, Fyn, Denmark
Research Site
Lyngby, Denmark
Research Site
Lystrup, Denmark
Research Site
Maeloev, Denmark
Research Site
Middelfart, Denmark
Research Site
Morud, Denmark
Research Site
Noerre Alslev, Denmark
Research Site
Noerresundby, Denmark
Research Site
Nyborg, Denmark
Research Site
Nykoebing F, Denmark
Research Site
Nærum, Denmark
Research Site
Næstved, Denmark
Research Site
Nørre Broby, Denmark
Research Site
Odense C, Denmark
Research Site
Odense NV, Denmark
Research Site
Oelstykke, Denmark
Research Site
Oksboel, Denmark
Research Site
Randers, Denmark
Research Site
Risskov, Denmark
Research Site
Roedovre, Denmark
Research Site
Roskilde, Denmark
Research Site
Roslev, Denmark
Research Site
Rudkoebing, Denmark
Research Site
Rungsted Kyst, Denmark
Research Site
Sakskoebing, Denmark
Research Site
Saltum, Denmark
Research Site
Skals, Denmark
Research Site
Skive, Denmark
Research Site
Skovlunde, Denmark
Research Site
Slagelse, Denmark
Research Site
Snekkersten, Denmark
Research Site
Soendersoe, Denmark
Research Site
Solroed Strand, Denmark
Research Site
Soroe, Denmark
Research Site
Stege, Denmark
Research Site
Stenlille, Denmark
Research Site
Struer Municipality, Denmark
Research Site
Svendborg, Denmark
Research Site
Svenstrup, Denmark
Research Site
Sæby, Denmark
Research Site
Sønderborg, Denmark
Research Site
Taastrup, Denmark
Research Site
Thorsoe, Denmark
Research Site
Toelloese, Denmark
Research Site
Toender, Denmark
Research Site
Ullerslev, Denmark
Research Site
Vaerloese, Denmark
Research Site
Vanloese, Denmark
Research Site
Varde, Denmark
Research Site
Vedbæk, Denmark
Research Site
Vejle, Denmark
Research Site
Viborg, Denmark
Research Site
Viby J, Denmark
Research Site
Vinderup, Denmark
Research Site
Virum, Denmark
Research Site
Viuf, Denmark
Research Site
Vojens, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Denmark Medical Director, MD
AstraZeneca A/S
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
October 16, 2005
First Posted
October 18, 2005
Study Start
February 1, 2003
Last Updated
March 26, 2009
Record last verified: 2009-03