Effect of an Internet Based Compliance Enhancement Tool in Subjects With Hypercholesterolemia

NCT ID: NCT00240357

Last Updated: 2009-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

1175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Brief Summary

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The purpose of the study is to determine whether an Internet based compliance tool is superior to common diet counselling in patients with hypercholesterolemia.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lifestyle Regulation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Denmark Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca A/S

Locations

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Aabenraa, , Denmark

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Aalborg, , Denmark

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Aarhus C, , Denmark

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Aerup, , Denmark

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Albertslund, , Denmark

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Ans, , Denmark

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Ålbæk, , Denmark

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Ålestrup, , Denmark

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Bagsværd, , Denmark

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Billund, , Denmark

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Birkeroed, , Denmark

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Broendby Strand, , Denmark

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Broenshoej, , Denmark

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Copenhagen V, , Denmark

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Elsingore, , Denmark

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Farum, , Denmark

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Fredericia, , Denmark

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Frederiksberg C, , Denmark

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Frederikshavn, , Denmark

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Frederikssund, , Denmark

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Gentofte Municipality, , Denmark

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Glesborg, , Denmark

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Glostrup Municipality, , Denmark

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Goerlev Sjaelland, , Denmark

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Grenå, , Denmark

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Greve, , Denmark

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Grindsted, , Denmark

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Hadsund, , Denmark

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Haslev, , Denmark

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Hårlev, , Denmark

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Hedehusene, , Denmark

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Hellerup, , Denmark

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Helsinge, , Denmark

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Herning, , Denmark

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Hilleroed, , Denmark

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Hoeng, , Denmark

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Hoersholm, , Denmark

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Holbæk, , Denmark

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Hornbæk, , Denmark

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Horsens, , Denmark

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Humlebæk, , Denmark

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Hvidovre, , Denmark

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Ikast, , Denmark

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Jægerspris, , Denmark

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Kalundborg, , Denmark

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Karlslunde, , Denmark

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Kåstrup, , Denmark

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Kjellerup, , Denmark

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Kokkedal, , Denmark

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Kolding, , Denmark

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Kongens Lyngby, , Denmark

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Kværndrup, , Denmark

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Langeskov, Fyn, , Denmark

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Lyngby, , Denmark

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Lystrup, , Denmark

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Maeloev, , Denmark

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Middelfart, , Denmark

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Morud, , Denmark

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Noerre Alslev, , Denmark

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Noerresundby, , Denmark

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Nyborg, , Denmark

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Nykoebing F, , Denmark

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Nærum, , Denmark

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Næstved, , Denmark

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Nørre Broby, , Denmark

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Odense C, , Denmark

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Odense NV, , Denmark

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Oelstykke, , Denmark

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Oksboel, , Denmark

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Randers, , Denmark

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Risskov, , Denmark

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Roedovre, , Denmark

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Roskilde, , Denmark

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Roslev, , Denmark

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Rudkoebing, , Denmark

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Rungsted Kyst, , Denmark

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Sakskoebing, , Denmark

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Saltum, , Denmark

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Skals, , Denmark

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Skive, , Denmark

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Skovlunde, , Denmark

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Slagelse, , Denmark

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Snekkersten, , Denmark

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Soendersoe, , Denmark

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Solroed Strand, , Denmark

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Soroe, , Denmark

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Stege, , Denmark

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Stenlille, , Denmark

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Struer Municipality, , Denmark

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Svendborg, , Denmark

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Svenstrup, , Denmark

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Sæby, , Denmark

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Sønderborg, , Denmark

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Taastrup, , Denmark

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Thorsoe, , Denmark

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Toelloese, , Denmark

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Toender, , Denmark

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Ullerslev, , Denmark

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Vaerloese, , Denmark

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Vanloese, , Denmark

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Varde, , Denmark

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Vedbæk, , Denmark

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Vejle, , Denmark

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Viborg, , Denmark

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Viby J, , Denmark

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Vinderup, , Denmark

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Virum, , Denmark

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Viuf, , Denmark

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Vojens, , Denmark

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Countries

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Denmark

Other Identifiers

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Orbital

Identifier Type: -

Identifier Source: secondary_id

D3560L00002

Identifier Type: -

Identifier Source: org_study_id

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