HypercholesterolemiaNCT00837083
Evaluation of Crestor® (Rosuvastatin) in Daily Practice
An observational study of Hypercholesterolemia, run by AstraZeneca.
Trial summary
This open label, non-interventional study is to show the efficacy of Crestor (rosuvastatin) in reduction of LDL-cholesterol and cardiovascular risk parameters in patients with hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 602 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Oct 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients (outpatient or hospitalised) in whom Crestor is indicated according to the current Summary of product characteristics (SPC)
Who may be able to join
- a patient with hypercholesterolemia who has been prescribed Crestoraccording to physician's judgement, irrespective of the inclusion in the study.
- no treatment with any statin in the last 3 months
Who cannot join
- hypersensitivity to rosuvastatin or any other ingredient of Crestor
- active liver disease, severe renal insufficiency
- myopathy or predisposing risk factors for myopathy/ rhabdomyolysis
- woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation
About this study
Official title: Open-Label Non-Interventional Evaluation of Efficacy of Crestor® (Rosuvastatin) in Reduction of LDL-Cholesterol and Cardiovascular Risk Parameters in Patients With Hypercholesterolaemia
This open label, non-interventional study is to show the efficacy of Crestor (rosuvastatin) in reduction of LDL-cholesterol and cardiovascular risk parameters in patients with hypercholesterolemia. Effectiveness is to be evaluated using the difference in LDL cholesterol level between the first and the second visit after 12 weeks.
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, cholesterol, LDL-cholesterol, rosuvastatin, Crestor
- Medical subject headings
- Hypercholesterolemia
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol reduction
Measured: 12 weeks
Secondary outcomes (3)
achievement of target levels of total cholesterol and LDL-cholesterol
Measured: 12 weeks
patient compliance
Measured: 12 weeks
change in coronary risk
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startJan 2007
- Study completionOct 2007
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
- Time perspective
- Prospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Matija Cevc, MD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837083
- Sponsor's protocol ID
- NIS-CSI-CRE-2006/1
- Other IDs
- NIS-CRE 01/06
- Status last verified
- Feb 2009
- First submitted
- 4 Feb 2009
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Non-Interventional Evaluation of Efficacy of Crestor® (Rosuvastatin) in Reduction of LDL-Cholesterol and Cardiovascular Risk Parameters in Patients With Hypercholesterolaemia
- ClinicalTrials.gov ID
- NCT00837083
- Acronym / sponsor ID
- NIS-CSI-CRE-2006/1
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, cholesterol, LDL-cholesterol, rosuvastatin, Crestor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 5 Feb 2009 (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.
This open label, non-interventional study is to show the efficacy of Crestor (rosuvastatin) in reduction of LDL-cholesterol and cardiovascular risk parameters in patients with hypercholesterolemia. Effectiveness is to be evaluated using the difference in LDL cholesterol level between the first and the second visit after 12 weeks.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients (outpatient or hospitalised) in whom Crestor is indicated according to the current Summary of product characteristics (SPC)
Key inclusion criteria (2 listed)
- a patient with hypercholesterolemia who has been prescribed Crestoraccording to physician's judgement, irrespective of the inclusion in the study.
- no treatment with any statin in the last 3 months
Key exclusion criteria (4 listed)
- hypersensitivity to rosuvastatin or any other ingredient of Crestor
- active liver disease, severe renal insufficiency
- myopathy or predisposing risk factors for myopathy/ rhabdomyolysis
- woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation
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
LDL-cholesterol reduction
Time frame: 12 weeks
3 secondary outcomes
achievement of target levels of total cholesterol and LDL-cholesterol
Time frame: 12 weeks
patient compliance
Time frame: 12 weeks
change in coronary risk
Time frame: 12 weeks
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 6 Feb 2009.
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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.
Matija Cevc, MD principal investigator
University Medical Centre Ljubljana
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by AstraZeneca.
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 2 inclusion and 4 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 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
LDL-cholesterol reduction (time frame: 12 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 6 Feb 2009.