HypercholesterolemiaNCT00240344
Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New LDL-C Target Goal
An observational study of Hypercholesterolemia, run by AstraZeneca at 75 sites in Netherlands.
Trial summary
The purpose of this study is to determine the efficacy of Crestor in high risk patients switched from higher doses of other statins in obtaining the new European Atherosclerosis Society (EAS) low-density lipoprotein cholesterol (LDL-C) guidelines. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 2,650 participants
- Where
- 75 sitesNetherlands
- Study dates
- Sep 2004to Feb 2008
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care
Who may be able to join
- High risk patients
- High doses of other statins
- LDL-C known, starts with Crestor 10 mg
- Permission to use patient data by AstraZeneca (AZ)
Who cannot join
None listed.
Trial locations and contacts
75 sites in 1 country.
75 sites in 1 country
Netherlands75 sites
Research Site
's-Hertogenbosch
Research Site
Alkmaar
Research Site
Almelo
Research Site
Alphen aan den Rijn
Research Site
Amsterdam
Research Site
Apeldoorn
Research Site
Assen
Research Site
Bergen op Zoom
Research Site
Beverwijk
Research Site
Bilthoven
Research Site
Blaricum
Research Site
Boxmeer
Research Site
Breda
Research Site
Brunssum
Research Site
Capelle aan den IJssel
Research Site
Delft
Research Site
Delfzijl
Research Site
Den Helder
Research Site
Dirksland
Research Site
Doetinchem
Research Site
Dokkum
Research Site
Dordrecht
Research Site
Drachten
Research Site
Ede Gld
Research Site
Eindhoven
Research Site
Emmen
Research Site
Enschede
Research Site
Etten-Leur
Research Site
Flushing
Research Site
Geldrop
Research Site
Gouda
Research Site
Groningen
Research Site
Haarlem
Research Site
Hardenberg
Research Site
Heerenveen
Research Site
Heerlen
Research Site
Helmond
Research Site
Hengelo Ov
Research Site
Hoofddorp
Research Site
Hoogeveen
Research Site
Hoorn
Research Site
IJmuiden
Research Site
Landsmeer
Research Site
Leiden
Research Site
Lelystad
Research Site
Maastricht
Research Site
Meppel
Research Site
Oosterhout Nb
Research Site
Oss
Research Site
Purmerend
Research Site
Roermond
Research Site
Roosendaal
Research Site
Rotterdam
Research Site
Schiedam
Research Site
Sneek
Research Site
Spijkenisse
Research Site
Stadskanaal
Research Site
Terneuzen
Research Site
The Hague
Research Site
Tiel
Research Site
Tilburg
Research Site
Utrecht
Research Site
Veghel
Research Site
Veldhoven
Research Site
Venlo
Research Site
Vlaardingen
Research Site
Waalwijk
Research Site
Weert
Research Site
Winschoten
Research Site
Winterswijk
Research Site
Zaandam
Research Site
Zevenaar
Research Site
Zoetermeer
Research Site
Zutphen
Research Site
Zwolle
About this study
Official title: REALISTIC: Protocol for an Observational Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New EAS LDL-C Target Goal
The purpose of this study is to determine the efficacy of Crestor in high risk patients switched from higher doses of other statins in obtaining the new European Atherosclerosis Society (EAS) low-density lipoprotein cholesterol (LDL-C) guidelines.
- Conditions
- Hypercholesterolemia
- Keywords
- High risk patients, Crestor, Rosuvastatin, LDL cholesterol, observational
- Medical subject headings
- Hypercholesterolemia
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 startSep 2004
- Primary completionFeb 2008
- Study completionFeb 2008
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca Netherlands Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240344
- Sponsor's protocol ID
- NL401142
- Other IDs
- REALISTIC
- Status last verified
- Aug 2011
- First submitted
- 16 Oct 2005
- Last updated
- 30 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REALISTIC: Protocol for an Observational Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New EAS LDL-C Target Goal
- ClinicalTrials.gov ID
- NCT00240344
- Acronym / sponsor ID
- NL401142
- Conditions
- Hypercholesterolemia
- Keywords
- High risk patients, Crestor, Rosuvastatin, LDL cholesterol, observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,650 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- 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 this study is to determine the efficacy of Crestor in high risk patients switched from higher doses of other statins in obtaining the new European Atherosclerosis Society (EAS) low-density lipoprotein cholesterol (LDL-C) guidelines.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care
Key inclusion criteria (4 listed)
- High risk patients
- High doses of other statins
- LDL-C known, starts with Crestor 10 mg
- Permission to use patient data by AstraZeneca (AZ)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
Related trials for Hypercholesterolemia
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Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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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 Netherlands Medical Director, MD study director
AstraZeneca
75 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by AstraZeneca at 75 sites in Netherlands.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 30 Aug 2011.