HypercholesteremiaNCT01477944
Pattern of Statins Use in Catalonia
An observational study of Hypercholesteremia, run by AstraZeneca.
Trial summary
To describe the new statins prescription pattern in Catalonia (getting their first prescription for any statin, or receiving a change in their statin treatment including switching, changing in doses or adding ezetimibe/fibrates) since September 2009. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesteremia
- How many people
- 180,723 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Feb 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: Hypercolesterolemic patients in treatment with statins.
Who may be able to join
- Patient with a new prescription of statin Patients receiving one or more changes of the statins treatment
Who cannot join
- Patient with not full information
About this study
To describe the new statins prescription pattern in Catalonia (getting their first prescription for any statin, or receiving a change in their statin treatment including switching, changing in doses or adding ezetimibe/fibrates) since September 2009.
Read the detailed description
Pattern of statins use in Catalonia.
- Conditions
- Hypercholesteremia
- Keywords
- Statins pattern of use, Hypercholesterolemic patients, Statins
- Medical subject headings
- Hypercholesterolemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of detailed clinical treatment in terms of duration of treatment, doses, drug switches and add-on therapy, in patients with hypercholesterolemia and on treatment with statins from the index date.
Measured: From 1st September 2009 to 30th August 2010
Type of prescriber
Number of patient, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner, etc.)
Measured: From 1st September 2009 to 30th August 2010
Date of change from previous statin to new.
Measured: From 1st September 2009 to 30th August 2010
Secondary outcomes (8)
Description of demographic data including: Sex, Age, Height (cm), Weight (kg), Smoking habits (packs-years), Alcohol consume habits (units/week), active worker or retired, Pregnancy.
Measured: From 1st September 2009 to 30th August 2010
Total cholesterol
Total Cholesterol data was collected till the last laboratory values before the date of change from previous statin to new statin.
That values will be collected for all the patients fulfilling criteria.
Measured: From 1st September 2009 to 30th August 2010
Low Density Lipoprotein (LDL) cholesterol concentration
LDL cholesterol data was collected till the last laboratory values before the date of change from previous statin to new statin.
Measured: From 1st September 2009 to 30th August 2010
High Density Lipoproteins (HDL) cholesterol concentration
HDL data was collected till the last laboratory values before the date of change from previous statin to new statin.
Measured: From 1st September 2009 to 30th August 2010
Triglicerides (TG) concentration
TG data was collected till the last laboratory values before the date of change from previous statin to new statin.
Measured: From 1st September 2009 to 30th August 2010
Aspartate Aminotransferase (ASAT) concentration
ASAT data was collected till the last laboratory values before the date of change from previous statin to new statin.
Measured: From 1st September 2009 to 30th August 2010
Serum Glucose concentration
Serum Glucose data was collected till the last laboratory values before the date of change from previous statin to new statin.
Measured: From 1st September 2009 to 30th August 2010
Serum Creatin Kinase (CK) concentration
CK data was collected till the last laboratory values before the date of change from previous statin to new statin.
Measured: From 1st September 2009 to 30th August 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesteremiaStudies 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
- 180,723 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477944
- Sponsor's protocol ID
- NIS-CES-CRE-2011/1
- Status last verified
- Feb 2012
- First submitted
- 18 Nov 2011
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Statins Use in Catalonia
- ClinicalTrials.gov ID
- NCT01477944
- Acronym / sponsor ID
- NIS-CES-CRE-2011/1
- Conditions
- Hypercholesteremia
- Keywords
- Statins pattern of use, Hypercholesterolemic patients, Statins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180,723 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 Nov 2011 (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.
To describe the new statins prescription pattern in Catalonia (getting their first prescription for any statin, or receiving a change in their statin treatment including switching, changing in doses or adding ezetimibe/fibrates) since September 2009.
Detailed description
Pattern of statins use in Catalonia.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypercolesterolemic patients in treatment with statins.
Key inclusion criteria (1 listed)
- Patient with a new prescription of statin Patients receiving one or more changes of the statins treatment
Key exclusion criteria (1 listed)
- Patient with not full information
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
Description of detailed clinical treatment in terms of duration of treatment, doses, drug switches and add-on therapy, in patients with hypercholesterolemia and on treatment with statins from the index date.
Time frame: From 1st September 2009 to 30th August 2010
Type of prescriber
Time frame: From 1st September 2009 to 30th August 2010
Number of patient, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner, etc.)
Date of change from previous statin to new.
Time frame: From 1st September 2009 to 30th August 2010
8 secondary outcomes
Description of demographic data including: Sex, Age, Height (cm), Weight (kg), Smoking habits (packs-years), Alcohol consume habits (units/week), active worker or retired, Pregnancy.
Time frame: From 1st September 2009 to 30th August 2010
Total cholesterol
Time frame: From 1st September 2009 to 30th August 2010
Low Density Lipoprotein (LDL) cholesterol concentration
Time frame: From 1st September 2009 to 30th August 2010
High Density Lipoproteins (HDL) cholesterol concentration
Time frame: From 1st September 2009 to 30th August 2010
Triglicerides (TG) concentration
Time frame: From 1st September 2009 to 30th August 2010
Aspartate Aminotransferase (ASAT) concentration
Time frame: From 1st September 2009 to 30th August 2010
Serum Glucose concentration
Time frame: From 1st September 2009 to 30th August 2010
Serum Creatin Kinase (CK) concentration
Time frame: From 1st September 2009 to 30th August 2010
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 22 Feb 2012.
Related trials for Hypercholesteremia
RecruitingPhase 2
Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis
Ischemic Stroke, Hypercholesteremia
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesteremia, 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 1 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: finished, as of the sponsor's last update on 22 Feb 2012. 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?
Description of detailed clinical treatment in terms of duration of treatment, doses, drug switches and add-on therapy, in patients with hypercholesterolemia and on treatment with statins from the index date. (time frame: From 1st September 2009 to 30th August 2010). The study lists 3 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 22 Feb 2012; AzTrials last refreshed its copy on 26 Oct 2026.