HypercholesterolemiaPhase 4NCT00240357
Effect of an Internet Based Compliance Enhancement Tool in Subjects With Hypercholesterolemia
A Phase 4 study testing Lifestyle Regulation in people with Hypercholesterolemia, run by AstraZeneca at 109 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Lifestyle Regulation
- Type of treatment
- Surgery or procedure
- How many people
- 1,175 participants
- Where
- 109 sitesDenmark
- Study dates
- Feb 2003to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
109 sites in 1 country.
109 sites in 1 country
Denmark109 sites
Research Site
Aabenraa
Research Site
Aalborg
Research Site
Aarhus C
Research Site
Aerup
Research Site
Ålbæk
Research Site
Albertslund
Research Site
Ålestrup
Research Site
Ans
Research Site
Bagsværd
Research Site
Billund
Research Site
Birkeroed
Research Site
Broendby Strand
Research Site
Broenshoej
Research Site
Copenhagen V
Research Site
Elsingore
Research Site
Farum
Research Site
Fredericia
Research Site
Frederiksberg C
Research Site
Frederikshavn
Research Site
Frederikssund
Research Site
Gentofte Municipality
Research Site
Glesborg
Research Site
Glostrup Municipality
Research Site
Goerlev Sjaelland
Research Site
Grenå
Research Site
Greve
Research Site
Grindsted
Research Site
Hadsund
Research Site
Hårlev
Research Site
Haslev
Research Site
Hedehusene
Research Site
Hellerup
Research Site
Helsinge
Research Site
Herning
Research Site
Hilleroed
Research Site
Hoeng
Research Site
Hoersholm
Research Site
Holbæk
Research Site
Hornbæk
Research Site
Horsens
Research Site
Humlebæk
Research Site
Hvidovre
Research Site
Ikast
Research Site
Jægerspris
Research Site
Kalundborg
Research Site
Karlslunde
Research Site
Kåstrup
Research Site
Kjellerup
Research Site
Kokkedal
Research Site
Kolding
Research Site
Kongens Lyngby
Research Site
Kværndrup
Research Site
Langeskov, Fyn
Research Site
Lyngby
Research Site
Lystrup
Research Site
Maeloev
Research Site
Middelfart
Research Site
Morud
Research Site
Nærum
Research Site
Næstved
Research Site
Noerre Alslev
Research Site
Noerresundby
Research Site
Nørre Broby
Research Site
Nyborg
Research Site
Nykoebing F
Research Site
Odense C
Research Site
Odense NV
Research Site
Oelstykke
Research Site
Oksboel
Research Site
Randers
Research Site
Risskov
Research Site
Roedovre
Research Site
Roskilde
Research Site
Roslev
Research Site
Rudkoebing
Research Site
Rungsted Kyst
Research Site
Sæby
Research Site
Sakskoebing
Research Site
Saltum
Research Site
Skals
Research Site
Skive
Research Site
Skovlunde
Research Site
Slagelse
Research Site
Snekkersten
Research Site
Soendersoe
Research Site
Solroed Strand
Research Site
Sønderborg
Research Site
Soroe
Research Site
Stege
Research Site
Stenlille
Research Site
Struer Municipality
Research Site
Svendborg
Research Site
Svenstrup
Research Site
Taastrup
Research Site
Thorsoe
Research Site
Toelloese
Research Site
Toender
Research Site
Ullerslev
Research Site
Vaerloese
Research Site
Vanloese
Research Site
Varde
Research Site
Vedbæk
Research Site
Vejle
Research Site
Viborg
Research Site
Viby J
Research Site
Vinderup
Research Site
Virum
Research Site
Viuf
Research Site
Vojens
About this study
Official title: Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement of LDL Goals. - Denmark
The purpose of the study is to determine whether an Internet based compliance tool is superior to common diet counselling in patients with hypercholesterolemia.
- Conditions
- Hypercholesterolemia
- Being tested
- Lifestyle Regulation
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle RegulationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startFeb 2003
Why it stopped: Study cancelled prior to FSI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,175 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Denmark Medical Director, MD, Study director, AstraZeneca A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240357
- Sponsor's protocol ID
- D3560L00002
- Other IDs
- Orbital
- Status last verified
- Mar 2009
- First submitted
- 16 Oct 2005
- Last updated
- 26 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement of LDL Goals. - Denmark
- ClinicalTrials.gov ID
- NCT00240357
- Acronym / sponsor ID
- D3560L00002
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled prior to FSI
- Enrolment
- 1,175 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- First posted
- 18 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether an Internet based compliance tool is superior to common diet counselling in patients with hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Regulation | Procedure or surgery | – |
Primary outcome
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).
6 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2009.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Denmark Medical Director, MD study director
AstraZeneca A/S
109 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lifestyle Regulation in people with Hypercholesterolemia, run by AstraZeneca at 109 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2009.