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

Primary Purpose

Hypercholesterolemia

Status
Withdrawn
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Lifestyle Regulation
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

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 Outcome Measures

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
Change in waistline after 6 months therapy

Full Information

First Posted
October 16, 2005
Last Updated
March 25, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00240357
Brief Title
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

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Study cancelled prior to FSI
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1175 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Lifestyle Regulation
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Number and percentage of subjects within the DSAM LDL-C target goal after 3 months therapy
Title
Compliance with study drug assessed by tablet count data
Title
Number and percentage of subjects increasing rosuvastatin dosage from 10 mg to 20 mg at week 12
Title
Percentage change in TC, HDL-C, LDL-C, TG from week 0 to week 24
Title
Change in weight after 6 months therapy
Title
Change in waistline after 6 months therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Denmark Medical Director, MD
Organizational Affiliation
AstraZeneca A/S
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aabenraa
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Denmark
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Aalbaek
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Denmark
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Aalborg
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Denmark
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Aarhus C
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Denmark
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Aerup
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Denmark
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Albertslund
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Denmark
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Ans by
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Denmark
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Bagsvaerd
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Denmark
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Billund
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Denmark
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Birkeroed
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Denmark
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Broby
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Denmark
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Broendby Strand
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Denmark
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Broenshoej
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Denmark
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Copenhagen V
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Denmark
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Elsingore
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Denmark
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Farum
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Denmark
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Fredericia
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Denmark
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Frederiksberg C
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Denmark
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Frederikshavn
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Denmark
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Frederikssund
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Denmark
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Gentofte
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Denmark
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Glesborg
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Denmark
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Glostrup
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Denmark
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Goerlev Sjaelland
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Denmark
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Grenå
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Denmark
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Greve
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Denmark
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Grindsted
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Denmark
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Haarlev
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Denmark
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Hadsund
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Denmark
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Haslev
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Denmark
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Hedehusene
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Denmark
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Hellerup
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Denmark
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Helsinge
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Denmark
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Herning
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Denmark
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Hilleroed
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Denmark
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Hoeng
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Denmark
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Hoersholm
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Denmark
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Holbaek
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Denmark
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Hornbaek
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Denmark
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Horsens
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Denmark
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Humlebaek
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Denmark
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Hvidovre
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Denmark
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Ikast
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Jaegerspris
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Kalundborg
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Karlslunde
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Kastrup
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Kgs. Lyngby
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Denmark
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Kjellerup
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Denmark
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Kokkedal
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Kolding
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Denmark
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Kvaerndrup
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Langeskov, Fyn
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Denmark
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Lyngby
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Lystrup
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Denmark
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Maeloev
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Denmark
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Middelfart
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Denmark
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Morud
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Denmark
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Naerum
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Denmark
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Naestved
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Denmark
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Noerre Alslev
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Denmark
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Noerresundby
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Denmark
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Nyborg
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Denmark
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Nykoebing F
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Denmark
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Odense C
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Denmark
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Odense NV
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Denmark
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Oelstykke
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Oksboel
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Randers
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Denmark
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Risskov
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Denmark
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Roedovre
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Denmark
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Roskilde
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Denmark
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Roslev
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Denmark
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Rudkoebing
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Rungsted Kyst
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Denmark
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Saeby
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Denmark
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Sakskoebing
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Saltum
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Skals
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Skive
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Skovlunde
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Slagelse
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Denmark
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Snekkersten
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Denmark
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Soenderborg
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Denmark
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Soendersoe
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Solroed Strand
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Soroe
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Stege
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Stenlille
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Struer
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Svendborg
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Denmark
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Svendstrup
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Taastrup
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Thorsoe
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Toelloese
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Toender
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Ullerslev
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Vaerloese
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Vanloese
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Varde
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Vedbaek
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Vejle
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Denmark
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Viborg
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Denmark
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Viby J
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Vinderup
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Virum
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Viuf
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Vojens
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Denmark
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Ålestrup
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Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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