Hypercholesterolemia Clinical Trial
Official title:
Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement of LDL Goals. - Denmark
| Verified date | March 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Medicines Agency |
| Study type | Interventional |
The purpose of the study is to determine whether an Internet based compliance tool is superior to common diet counselling in patients with hypercholesterolemia.
| Status | Withdrawn |
| Enrollment | 1175 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Research Site | Aabenraa | |
| Denmark | Research Site | Aalbaek | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Aarhus C | |
| Denmark | Research Site | Aerup | |
| Denmark | Research Site | Albertslund | |
| Denmark | Research Site | Ålestrup | |
| Denmark | Research Site | Ans by | |
| Denmark | Research Site | Bagsvaerd | |
| Denmark | Research Site | Billund | |
| Denmark | Research Site | Birkeroed | |
| Denmark | Research Site | Broby | |
| 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 | |
| Denmark | Research Site | Glesborg | |
| Denmark | Research Site | Glostrup | |
| Denmark | Research Site | Goerlev Sjaelland | |
| Denmark | Research Site | Grenå | |
| Denmark | Research Site | Greve | |
| Denmark | Research Site | Grindsted | |
| Denmark | Research Site | Haarlev | |
| Denmark | Research Site | Hadsund | |
| Denmark | Research Site | Haslev | |
| 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 | Holbaek | |
| Denmark | Research Site | Hornbaek | |
| Denmark | Research Site | Horsens | |
| Denmark | Research Site | Humlebaek | |
| Denmark | Research Site | Hvidovre | |
| Denmark | Research Site | Ikast | |
| Denmark | Research Site | Jaegerspris | |
| Denmark | Research Site | Kalundborg | |
| Denmark | Research Site | Karlslunde | |
| Denmark | Research Site | Kastrup | |
| Denmark | Research Site | Kgs. Lyngby | |
| Denmark | Research Site | Kjellerup | |
| Denmark | Research Site | Kokkedal | |
| Denmark | Research Site | Kolding | |
| Denmark | Research Site | Kvaerndrup | |
| 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 | Naerum | |
| Denmark | Research Site | Naestved | |
| Denmark | Research Site | Noerre Alslev | |
| Denmark | Research Site | Noerresundby | |
| Denmark | Research Site | Nyborg | |
| Denmark | Research Site | Nykoebing F | |
| 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 | Saeby | |
| 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 | Soenderborg | |
| 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 | |
| Denmark | Research Site | Svendborg | |
| Denmark | Research Site | Svendstrup | |
| 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 | Vedbaek | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Number and percentage of subjects within the DSAM LDL-C target goal after 3 months therapy | |||
| Secondary | Compliance with study drug assessed by tablet count data | |||
| Secondary | Number and percentage of subjects increasing rosuvastatin dosage from 10 mg to 20 mg at week 12 | |||
| Secondary | Percentage change in TC, HDL-C, LDL-C, TG from week 0 to week 24 | |||
| Secondary | Change in weight after 6 months therapy | |||
| Secondary | Change in waistline after 6 months therapy |
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