DyslipidemiaNCT00726856
Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)
An observational study of Dyslipidemia, run by Organon and Co.
Trial summary
This retrospective study evaluates the effectiveness and safety of ezetimibe plus statin or ezetimibe plus fenofibrate in dyslipidemic patients that were treated with these dual inhibition lipid lowering regimens as part of their normal standard of care. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jul 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with dyslipidemia who did not respond adequately based on NCEP ATP III target to previous lipid lowering treatment, and have received dual inhibition therapy, such as ezetimibe plus statins, ezetimibe plus fenofibrate or ezetimibe alone, for at least 3 months
Who may be able to join
- Patient was > 20 years and < 75 years of age on the index date*
- Patient diagnosed with dyslipidemia who did not respond adequately based on NCEP ATP III target to previous lipid lowering treatment, and have received dual inhibition therapy, such as ezetimibe plus statins, ezetimibe plus fenofibrate or ezetimibe alone, for at least 3 months
- Patient has at least one Total Cholesterol and LDL-C measurements at baseline and 3 months after initiating the dual inhibition therapy.
- Patient has the following records documented in the chart during the data collection period:
- Medical history and co morbidities (if available)
- Total Cholesterol and LDL-C. test results before and after initiating the dual inhibition therapy
- Prescription information of lipid-lowering dual inhibition regimens NOTE: * Index date: the date of initiating dual inhibition therapy
Who cannot join
- Patients who do not meet all the inclusion criteria will be excluded from this survey.
- Patients who were enrolled in other clinical trial observing specific study procedures which deviates from normal practice will not be included in this study.
About this study
Official title: A Retrospective Survey to Evaluate the Effectiveness and Safety of Dual Inhibition Lipid-lowering Regimen in the Treatment of Dyslipidemic Patients in Normal Practice
This retrospective study evaluates the effectiveness and safety of ezetimibe plus statin or ezetimibe plus fenofibrate in dyslipidemic patients that were treated with these dual inhibition lipid lowering regimens as part of their normal standard of care. This study assesses the percentage of patients who achieve LDL-C target goals and also evaluates the patient compliance to treatment.
Read the detailed description
Retrospective medical chart review
- Conditions
- Dyslipidemia
- Being tested
- Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrateDrug
Also called SCH 58235
Ezetimibe 10 mg taken daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Patients | patients with dyslipidemia Receives: Drug: Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the change in LDL-C levels after treatment
Measured: 3 months
Secondary outcomes (4)
Assessment of the percentage of patients who attain their National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III target for LDL-C
Measured: 3 months
Assessment of patient compliance by evaluating the length of stay on therapy
Measured: 3 months
Comparison of the patient comorbidities among populations gathered from different levels of hospitals and specialties
Measured: 3 months
Evaluation of safety and tolerability in patients receiving dual inhibition therapy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startMay 2007
- Primary completionJul 2007
- Study completionJul 2007
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726856
- Sponsor's protocol ID
- P05171
- Status last verified
- Feb 2022
- First submitted
- 30 Jul 2008
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Survey to Evaluate the Effectiveness and Safety of Dual Inhibition Lipid-lowering Regimen in the Treatment of Dyslipidemic Patients in Normal Practice
- ClinicalTrials.gov ID
- NCT00726856
- Acronym / sponsor ID
- P05171
- Conditions
- Dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 1 Aug 2008 (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 retrospective study evaluates the effectiveness and safety of ezetimibe plus statin or ezetimibe plus fenofibrate in dyslipidemic patients that were treated with these dual inhibition lipid lowering regimens as part of their normal standard of care. This study assesses the percentage of patients who achieve LDL-C target goals and also evaluates the patient compliance to treatment.
Detailed description
Retrospective medical chart review
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibratepatients with dyslipidemia |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with dyslipidemia who did not respond adequately based on NCEP ATP III target to previous lipid lowering treatment, and have received dual inhibition therapy, such as ezetimibe plus statins, ezetimibe plus fenofibrate or ezetimibe alone, for at least 3 months
Key inclusion criteria (7 listed)
- Patient was > 20 years and < 75 years of age on the index date*
- Patient diagnosed with dyslipidemia who did not respond adequately based on NCEP ATP III target to previous lipid lowering treatment, and have received dual inhibition therapy, such as ezetimibe plus statins, ezetimibe plus fenofibrate or ezetimibe alone, for at least 3 months
- Patient has at least one Total Cholesterol and LDL-C measurements at baseline and 3 months after initiating the dual inhibition therapy.
- Patient has the following records documented in the chart during the data collection period:
Key exclusion criteria (2 listed)
- Patients who do not meet all the inclusion criteria will be excluded from this survey.
- Patients who were enrolled in other clinical trial observing specific study procedures which deviates from normal practice will not be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrateAlso: SCH 58235Ezetimibe 10 mg taken daily for 3 months | Drug | Patients |
Primary outcome
Evaluation of the change in LDL-C levels after treatment
Time frame: 3 months
4 secondary outcomes
Assessment of the percentage of patients who attain their National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III target for LDL-C
Time frame: 3 months
Assessment of patient compliance by evaluating the length of stay on therapy
Time frame: 3 months
Comparison of the patient comorbidities among populations gathered from different levels of hospitals and specialties
Time frame: 3 months
Evaluation of safety and tolerability in patients receiving dual inhibition therapy
Time frame: 3 months
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 16 Feb 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia, run by Organon and Co.
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 7 inclusion and 2 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 16 Feb 2022. 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?
Evaluation of the change in LDL-C levels after treatment (time frame: 3 months). 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 16 Feb 2022.