Clinical trial NCT00240357: Effect of an Internet Based Compliance Enhancement Tool in Subjects With Hypercholesterolemia
Official title: Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement of LDL Goals. - Denmark
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 1175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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:
measure: Number and percentage of subjects within the DSAM LDL-C target goal after 3 months therapy
measure: Compliance with study drug assessed by tablet count data
measure: Number and percentage of subjects increasing rosuvastatin dosage from 10 mg to 20 mg at week 12
measure: Percentage change in TC, HDL-C, LDL-C, TG from week 0 to week 24
measure: Change in weight after 6 months therapy
measure: Change in waistline after 6 months therapy
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Research Site
city: Aalbaek
country: Denmark
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Aarhus C
country: Denmark
facility: Research Site
city: Aerup
country: Denmark
facility: Research Site
city: Albertslund
country: Denmark
facility: Research Site
city: Ans by
country: Denmark
facility: Research Site
city: Bagsvaerd
country: Denmark
facility: Research Site
city: Billund
country: Denmark
facility: Research Site
city: Birkeroed
country: Denmark
facility: Research Site
city: Broby
country: Denmark
facility: Research Site
city: Broendby Strand
country: Denmark
facility: Research Site
city: Broenshoej
country: Denmark
facility: Research Site
city: Copenhagen V
country: Denmark
facility: Research Site
city: Elsingore
country: Denmark
facility: Research Site
city: Farum
country: Denmark
facility: Research Site
city: Fredericia
country: Denmark
facility: Research Site
city: Frederiksberg C
country: Denmark
facility: Research Site
city: Frederikshavn
country: Denmark
facility: Research Site
city: Frederikssund
country: Denmark
facility: Research Site
city: Gentofte
country: Denmark
facility: Research Site
city: Glesborg
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Goerlev Sjaelland
country: Denmark
facility: Research Site
city: Grenå
country: Denmark
facility: Research Site
city: Greve
country: Denmark
facility: Research Site
city: Grindsted
country: Denmark
facility: Research Site
city: Haarlev
country: Denmark
facility: Research Site
city: Hadsund
country: Denmark
facility: Research Site
city: Haslev
country: Denmark
facility: Research Site
city: Hedehusene
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: Helsinge
country: Denmark
facility: Research Site
city: Herning
country: Denmark
facility: Research Site
city: Hilleroed
country: Denmark
facility: Research Site
city: Hoeng
country: Denmark
facility: Research Site
city: Hoersholm
country: Denmark
facility: Research Site
city: Holbaek
country: Denmark
facility: Research Site
city: Hornbaek
country: Denmark
facility: Research Site
city: Horsens
country: Denmark
facility: Research Site
city: Humlebaek
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Ikast
country: Denmark
facility: Research Site
city: Jaegerspris
country: Denmark
facility: Research Site
city: Kalundborg
country: Denmark
facility: Research Site
city: Karlslunde
country: Denmark
facility: Research Site
city: Kastrup
country: Denmark
facility: Research Site
city: Kgs. Lyngby
country: Denmark
facility: Research Site
city: Kjellerup
country: Denmark
facility: Research Site
city: Kokkedal
country: Denmark
facility: Research Site
city: Kolding
country: Denmark
facility: Research Site
city: Kvaerndrup
country: Denmark
facility: Research Site
city: Langeskov, Fyn
country: Denmark
facility: Research Site
city: Lyngby
country: Denmark
facility: Research Site
city: Lystrup
country: Denmark
facility: Research Site
city: Maeloev
country: Denmark
facility: Research Site
city: Middelfart
country: Denmark
facility: Research Site
city: Morud
country: Denmark
facility: Research Site
city: Naerum
country: Denmark
facility: Research Site
city: Naestved
country: Denmark
facility: Research Site
city: Noerre Alslev
country: Denmark
facility: Research Site
city: Noerresundby
country: Denmark
facility: Research Site
city: Nyborg
country: Denmark
facility: Research Site
city: Nykoebing F
country: Denmark
facility: Research Site
city: Odense C
country: Denmark
facility: Research Site
city: Odense NV
country: Denmark
facility: Research Site
city: Oelstykke
country: Denmark
facility: Research Site
city: Oksboel
country: Denmark
facility: Research Site
city: Randers
country: Denmark
facility: Research Site
city: Risskov
country: Denmark
facility: Research Site
city: Roedovre
country: Denmark
facility: Research Site
city: Roskilde
country: Denmark
facility: Research Site
city: Roslev
country: Denmark
facility: Research Site
city: Rudkoebing
country: Denmark
facility: Research Site
city: Rungsted Kyst
country: Denmark
facility: Research Site
city: Saeby
country: Denmark
facility: Research Site
city: Sakskoebing
country: Denmark
facility: Research Site
city: Saltum
country: Denmark
facility: Research Site
city: Skals
country: Denmark
facility: Research Site
city: Skive
country: Denmark
facility: Research Site
city: Skovlunde
country: Denmark
facility: Research Site
city: Slagelse
country: Denmark
facility: Research Site
city: Snekkersten
country: Denmark
facility: Research Site
city: Soenderborg
country: Denmark
facility: Research Site
city: Soendersoe
country: Denmark
facility: Research Site
city: Solroed Strand
country: Denmark
facility: Research Site
city: Soroe
country: Denmark
facility: Research Site
city: Stege
country: Denmark
facility: Research Site
city: Stenlille
country: Denmark
facility: Research Site
city: Struer
country: Denmark
facility: Research Site
city: Svendborg
country: Denmark
facility: Research Site
city: Svendstrup
country: Denmark
facility: Research Site
city: Taastrup
country: Denmark
facility: Research Site
city: Thorsoe
country: Denmark
facility: Research Site
city: Toelloese
country: Denmark
facility: Research Site
city: Toender
country: Denmark
facility: Research Site
city: Ullerslev
country: Denmark
facility: Research Site
city: Vaerloese
country: Denmark
facility: Research Site
city: Vanloese
country: Denmark
facility: Research Site
city: Varde
country: Denmark
facility: Research Site
city: Vedbaek
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Viborg
country: Denmark
facility: Research Site
city: Viby J
country: Denmark
facility: Research Site
city: Vinderup
country: Denmark
facility: Research Site
city: Virum
country: Denmark
facility: Research Site
city: Viuf
country: Denmark
facility: Research Site
city: Vojens
country: Denmark
facility: Research Site
city: Ålestrup
country: Denmark
facility: Research Site
Study officials:
affiliation: AstraZeneca A/S
name: AstraZeneca Denmark Medical Director, MD
role: STUDY_DIRECTOR
References: