Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT00240357
Status:
WITHDRAWN
Last Update Posted:
2009-03-26
First Post:
2005-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of an Internet Based Compliance Enhancement Tool in Subjects With Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1175}}, 'statusModule': {'whyStopped': 'Study cancelled prior to FSI', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'lastUpdateSubmitDate': '2009-03-25', 'studyFirstSubmitDate': '2005-10-16', 'studyFirstSubmitQcDate': '2005-10-16', 'lastUpdatePostDateStruct': {'date': '2009-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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).'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether an Internet based compliance tool is superior to common diet counselling in patients with hypercholesterolemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Available personal mailbox and access to the Internet\n* 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\n* Fasting LDL-C level \\> 3.2 mmol/L\n\nExclusion Criteria:\n\n* Known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)\n* Documented secondary hypercholesterolemia of any cause except stable diabetes mellitus (type 1 or type 2)\n* History of serious adverse effect or hypersensitivity reactions to statins, in particular any history of myopathy'}, 'identificationModule': {'nctId': 'NCT00240357', 'briefTitle': 'Effect of an Internet Based Compliance Enhancement Tool in Subjects With Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement of LDL Goals. - Denmark', 'orgStudyIdInfo': {'id': 'D3560L00002'}, 'secondaryIdInfos': [{'id': 'Orbital'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Lifestyle Regulation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aabenraa', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}, {'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}, {'city': 'Aerup', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Albertslund', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.65691, 'lon': 12.36381}}, {'city': 'Ans', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.30712, 'lon': 9.59276}}, {'city': 'Ålbæk', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.59253, 'lon': 10.40456}}, {'city': 'Ålestrup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.6947, 'lon': 9.49336}}, {'city': 'Bagsværd', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.76095, 'lon': 12.45317}}, {'city': 'Billund', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.73349, 'lon': 9.10785}}, {'city': 'Birkeroed', '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', 'geoPoint': {'lat': 55.80858, 'lon': 12.36066}}, {'city': 'Fredericia', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.56568, 'lon': 9.75257}}, {'city': 'Frederiksberg C', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Frederikshavn', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.44073, 'lon': 10.53661}}, {'city': 'Frederikssund', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.83956, 'lon': 12.06896}}, {'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}, {'city': 'Glesborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.47747, 'lon': 10.72334}}, {'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'city': 'Goerlev Sjaelland', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Grenå', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.41578, 'lon': 10.87825}}, {'city': 'Greve', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.58333, 'lon': 12.3}}, {'city': 'Grindsted', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75726, 'lon': 8.9275}}, {'city': 'Hadsund', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.71482, 'lon': 10.11682}}, {'city': 'Haslev', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.32346, 'lon': 11.96389}}, {'city': 'Hårlev', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.34936, 'lon': 12.23382}}, {'city': 'Hedehusene', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.64951, 'lon': 12.19827}}, {'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'city': 'Helsinge', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.02283, 'lon': 12.19752}}, {'city': 'Herning', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'city': 'Hilleroed', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Hoeng', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Hoersholm', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Holbæk', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}, {'city': 'Hornbæk', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.09027, 'lon': 12.45693}}, {'city': 'Horsens', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}, {'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}, {'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'Ikast', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.13883, 'lon': 9.15768}}, {'city': 'Jægerspris', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.85248, 'lon': 11.98565}}, {'city': 'Kalundborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.67954, 'lon': 11.08864}}, {'city': 'Karlslunde', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.57258, 'lon': 12.22576}}, {'city': 'Kåstrup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.02706, 'lon': 8.73185}}, {'city': 'Kjellerup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.28581, 'lon': 9.43528}}, {'city': 'Kokkedal', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.91179, 'lon': 12.49952}}, {'city': 'Kolding', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}, {'city': 'Kongens Lyngby', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.77044, 'lon': 12.50378}}, {'city': 'Kværndrup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.17752, 'lon': 10.52549}}, {'city': 'Langeskov, Fyn', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.35655, 'lon': 10.58447}}, {'city': 'Lyngby', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.86974, 'lon': 8.31476}}, {'city': 'Lystrup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.49839, 'lon': 10.46887}}, {'city': 'Maeloev', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Middelfart', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.50591, 'lon': 9.73054}}, {'city': 'Morud', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.44814, 'lon': 10.18962}}, {'city': 'Noerre Alslev', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Noerresundby', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Nyborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.31274, 'lon': 10.78964}}, {'city': 'Nykoebing F', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Nærum', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.81597, 'lon': 12.53846}}, {'city': 'Næstved', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'city': 'Nørre Broby', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.25164, 'lon': 10.22953}}, {'city': 'Odense C', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'city': 'Odense NV', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.41934, 'lon': 10.29114}}, {'city': 'Oelstykke', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Oksboel', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Randers', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}, {'city': 'Risskov', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.19716, 'lon': 10.248}}, {'city': 'Roedovre', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}, {'city': 'Roslev', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.70387, 'lon': 8.98638}}, {'city': 'Rudkoebing', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Rungsted Kyst', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.88547, 'lon': 12.53034}}, {'city': 'Sakskoebing', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Saltum', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.27192, 'lon': 9.698}}, {'city': 'Skals', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.55676, 'lon': 9.40381}}, {'city': 'Skive', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.56699, 'lon': 9.02707}}, {'city': 'Skovlunde', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.71565, 'lon': 12.39802}}, {'city': 'Slagelse', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}, {'city': 'Snekkersten', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.00905, 'lon': 12.58595}}, {'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', 'geoPoint': {'lat': 54.98704, 'lon': 12.28461}}, {'city': 'Stenlille', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.53888, 'lon': 11.5912}}, {'city': 'Struer Municipality', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.49205, 'lon': 8.59397}}, {'city': 'Svendborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.05982, 'lon': 10.60677}}, {'city': 'Svenstrup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.60263, 'lon': 9.94361}}, {'city': 'Sæby', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.33188, 'lon': 10.52251}}, {'city': 'Sønderborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 54.90896, 'lon': 9.78917}}, {'city': 'Taastrup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.65006, 'lon': 12.3016}}, {'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', 'geoPoint': {'lat': 55.36172, 'lon': 10.6519}}, {'city': 'Vaerloese', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Vanloese', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Varde', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.62112, 'lon': 8.48069}}, {'city': 'Vedbæk', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.84729, 'lon': 12.56886}}, {'city': 'Vejle', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'city': 'Viborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}, {'city': 'Viby J', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.12259, 'lon': 10.15145}}, {'city': 'Vinderup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.48176, 'lon': 8.77991}}, {'city': 'Virum', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.79488, 'lon': 12.45103}}, {'city': 'Viuf', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.58526, 'lon': 9.49238}}, {'city': 'Vojens', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.24639, 'lon': 9.30603}}], 'overallOfficials': [{'name': 'AstraZeneca Denmark Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}