DyslipidemiaNCT01164397
Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin in Outpatients
An observational study of Dyslipidemia, run by AstraZeneca at 9 sites in Mexico.
Trial summary
The aim of this study is to evaluate the effectiveness of Rosuvastatin versus Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia
- How many people
- 268 participants
- Where
- 9 sitesMexico
- Study dates
- Apr 2009to Dec 2010
- 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: Care clinic private practice
Who may be able to join
- Dislipidemic population treated with rosuvastatin or ezetimibe/simvastatin for at least for 8 weeks
- Who have completed at least 80% of the treatment
- To have determinations at least of CT, TG C-LDL and CHDL before starting treatment and after 8 weeks of taking the medicine
Who cannot join
- Initiating different therapy lipid lowering to Rosuvastatin or Ezetimibe/Simvastatin
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Mexico9 sites
Research Site
Cuernavaca, Morelos
Research Site
Durango
Research Site
Guadalajara, Jalisco
Research Site
Mérida, Yucatán
Research Site
Mexico City, Mexico City
Research Site
Monterrey, Nuevo León
Research Site
Puebla City, Puebla
Research Site
San Luis Potosí City, San Luis Potosí
Research Site
Veracruz, Xalapa
About this study
Official title: Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin to Reduce the Cholesterol Levels in Outpatients in a Realistic Environment. A Retrospective Study
The aim of this study is to evaluate the effectiveness of Rosuvastatin versus Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks.
- Conditions
- Dyslipidemia
- Keywords
- Hypercholesterolemia, Statins
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia
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 |
|---|---|---|
| Dislipidemic Population | People with high levels of total cholesterol, LDL, C-HDL and triglycerides |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of the patients that achieve the goal proposed for NCEP ATP III (2001 y 2004) will be assessed, to C-LDL in patients treated with Rosuvastatin or Ezetimibe/Simvastatin at least for 8 weeks.
Measured: Data will be collected using CRFs after complete at least 15 patients over a 24 week period.
Secondary outcomes (1)
The percentage of LDL-C reduction according to baseline levels in patients treated wuth Rosuvastatin or Ezetimibe/Simvastatin for at least 8 weeks.
Measured: Data will be collected using CRFs after complete at least 15 patients over a 24 week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startApr 2009
- Study completionDec 2010
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana Polanco, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164397
- Sponsor's protocol ID
- NIS-CME-CRE-2010/1
- Other IDs
- DM-CRESTOR-0003
- Status last verified
- Jan 2012
- First submitted
- 28 May 2010
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin to Reduce the Cholesterol Levels in Outpatients in a Realistic Environment. A Retrospective Study
- ClinicalTrials.gov ID
- NCT01164397
- Acronym / sponsor ID
- NIS-CME-CRE-2010/1
- Conditions
- Dyslipidemia
- Keywords
- Hypercholesterolemia, Statins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Jul 2010 (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 aim of this study is to evaluate the effectiveness of Rosuvastatin versus Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dislipidemic Population | – | –People with high levels of total cholesterol, LDL, C-HDL and triglycerides |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Care clinic private practice
Key inclusion criteria (3 listed)
- Dislipidemic population treated with rosuvastatin or ezetimibe/simvastatin for at least for 8 weeks
- Who have completed at least 80% of the treatment
- To have determinations at least of CT, TG C-LDL and CHDL before starting treatment and after 8 weeks of taking the medicine
Key exclusion criteria (1 listed)
- Initiating different therapy lipid lowering to Rosuvastatin or Ezetimibe/Simvastatin
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
The percentage of the patients that achieve the goal proposed for NCEP ATP III (2001 y 2004) will be assessed, to C-LDL in patients treated with Rosuvastatin or Ezetimibe/Simvastatin at least for 8 weeks.
Time frame: Data will be collected using CRFs after complete at least 15 patients over a 24 week period.
1 secondary outcome
The percentage of LDL-C reduction according to baseline levels in patients treated wuth Rosuvastatin or Ezetimibe/Simvastatin for at least 8 weeks.
Time frame: Data will be collected using CRFs after complete at least 15 patients over a 24 week period.
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 18 Jan 2012.
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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.
Ana Polanco, MD study director
AstraZeneca
9 sites 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 9 sites in Mexico.
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 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 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Mexico. 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.
What does the primary outcome measure?
The percentage of the patients that achieve the goal proposed for NCEP ATP III (2001 y 2004) will be assessed, to C-LDL in patients treated with Rosuvastatin or Ezetimibe/Simvastatin at least for 8 weeks. (time frame: Data will be collected using CRFs after complete at least 15 patients over a 24 week period.). 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 18 Jan 2012.