DyslipidemiaNCT01023503
Observational Study To Evaluate Statins Patterns Of Use In Spain
An observational study of Dyslipidemia, run by AstraZeneca at 1 site in Spain.
Trial summary
The present project is aimed at describing the statins prescription pattern in Spanish patients. It will also look into how adequate these prescriptions are accordingly to the recommendations given in Treatment Guidelines and in the Summary Product Information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Jul 2012
- 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: To be recruited by Primary Care Physicians
Who may be able to join
- Patients receiving a new statin prescription (naïve patients)
- Patients having a change in their statin prescription (dose, switching, addition to another hypolipemic drug)
Who cannot join
- Patients without enough information in the medical records to complete the fields required in the eCRF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Statins Use Patterns in Spain
The present project is aimed at describing the statins prescription pattern in Spanish patients. It will also look into how adequate these prescriptions are accordingly to the recommendations given in Treatment Guidelines and in the Summary Product Information.
- Conditions
- Dyslipidemia
- Keywords
- Statins, Dyslipidemia, Spain, Rosuvastatin, Naive, Switching, New statins prescriptions in Spain (naive patients and switching)
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Adults, with a new statin prescription or a change in their stain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current and previous hypolipemic treatment, dose and pattern
Measured: Retrospectively (information for the previous 6-months). Information collected once.
Statin treatment start date, origin of the prescription, reasons for changes in prescription
Measured: Retrospectively (information for the previous 6-months). Information collected once.
Secondary outcomes (3)
Socio-demographic characteristics
Measured: retrospectively
Total Cholesterol, HDL, LDL, Triglycerides, ALAT, Glucose, Creatine Kinase plasma levels
Measured: retrospectively
Concomitant Treatments and Cardiovascular History
Measured: retrospectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startMar 2011
- Primary completionApr 2012 (estimated)
- Study completionJul 2012 (estimated)
Why it stopped: Changes affecting Post Authorization Study Regulatory effective from Dec09, impacted the requirements for Spanish studies at National and Regional level.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundació Institut Català de Farmacologia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023503
- Sponsor's protocol ID
- NIS-CES-CRE-2009/1
- Status last verified
- Jul 2013
- First submitted
- 31 Oct 2009
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins Use Patterns in Spain
- ClinicalTrials.gov ID
- NCT01023503
- Acronym / sponsor ID
- NIS-CES-CRE-2009/1
- Conditions
- Dyslipidemia
- Keywords
- Statins, Dyslipidemia, Spain, Rosuvastatin, Naive, Switching, New statins prescriptions in Spain (naive patients and switching)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Changes affecting Post Authorization Study Regulatory effective from Dec09, impacted the requirements for Spanish studies at National and Regional level.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Fundació Institut Català de Farmacologia
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 2 Dec 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.
The present project is aimed at describing the statins prescription pattern in Spanish patients. It will also look into how adequate these prescriptions are accordingly to the recommendations given in Treatment Guidelines and in the Summary Product Information.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adults, with a new statin prescription or a change in their stain treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To be recruited by Primary Care Physicians
Key inclusion criteria (2 listed)
- Patients receiving a new statin prescription (naïve patients)
- Patients having a change in their statin prescription (dose, switching, addition to another hypolipemic drug)
Key exclusion criteria (1 listed)
- Patients without enough information in the medical records to complete the fields required in the eCRF
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
Current and previous hypolipemic treatment, dose and pattern
Time frame: Retrospectively (information for the previous 6-months). Information collected once.
Statin treatment start date, origin of the prescription, reasons for changes in prescription
Time frame: Retrospectively (information for the previous 6-months). Information collected once.
3 secondary outcomes
Socio-demographic characteristics
Time frame: retrospectively
Total Cholesterol, HDL, LDL, Triglycerides, ALAT, Glucose, Creatine Kinase plasma levels
Time frame: retrospectively
Concomitant Treatments and Cardiovascular History
Time frame: retrospectively
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 24 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia, run by AstraZeneca at 1 site in Spain.
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 1 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 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 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?
Current and previous hypolipemic treatment, dose and pattern (time frame: Retrospectively (information for the previous 6-months). Information collected once.). The study lists 2 primary outcomes in all. 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 24 Jul 2013.