HyperlipidemiaCOLLNCT00828945
Compliance With Treatment For Patients With Hyperlipidemia
An observational study of Hyperlipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in Sweden.
Trial summary
It is a prospective observational study. Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin. Patients will be enrolled at a normal clinic visit and provided with a small box containing info about the disease, a LDL self-test and two questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Lipid Self Test
- Type of treatment
- Medical device
- How many people
- 259 participants
- Where
- 17 sitesSweden
- Study dates
- Feb 2009to Mar 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Aged 18 years or older and able to understand and sign the informed consent form. • Patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular disease prescribed statin treatment according to clinical praxis and the recommendations set forth in the MPA national guideline for treatment of hyperlipidemia.
Who may be able to join
- Aged 18 years or older and able to understand and sign the informed consent form.
- Patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular disease prescribed statin treatment according to clinical praxis and the recommendations set forth in the MPA national guideline for treatment of hyperlipidemia.
Who cannot join
- Patients contraindicated for statin treatment according to market authorization for these drugs should be excluded from the study.
- Patients participating in other clinical trials or non-interventional studies.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Sweden17 sites
Pfizer Investigational Site
Åkersberga, 184 27
Pfizer Investigational Site
Forshaga, 667 32
Pfizer Investigational Site
Gothenburg, 405 30
Pfizer Investigational Site
Gothenburg, 415 10
Pfizer Investigational Site
Gothenburg, 41665
Pfizer Investigational Site
Höganäs, 263 36
Pfizer Investigational Site
Jönköping, 553 16
Pfizer Investigational Site
Lessebo, 360 50
Pfizer Investigational Site
Lilla Edet, 46330
Pfizer Investigational Site
Limhamn, 216 43
Pfizer Investigational Site
Malmö, 211 20
Pfizer Investigational Site
Oviken, 830 24
Pfizer Investigational Site
Partille, 433 34
Pfizer Investigational Site
Stockholm, 111 35
Pfizer Investigational Site
Täby, 183 30
Pfizer Investigational Site
Trollhättan, 461 53
Pfizer Investigational Site
Västerås, 722 11
About this study
Official title: A Non-Randomized, Non-Controlled, Open Study In Order To Document The Compliance With Treatment, According To Clinical Praxis And National Guidelines For Patients With Hyperlipidemia. COLL: Control Of Lipid Lowering
It is a prospective observational study.
Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin. Patients will be enrolled at a normal clinic visit and provided with a small box containing info about the disease, a LDL self-test and two questionnaires. They will test themselves for LDL at home between normal clinic visits (normally 12 months interval) and note their value. In the end of the study all patients will fill out a questionnaire with questions if the tests and info have raised their awareness of the disease as well if their motivation to be compliant has increased.
We want to look at the possibility to put more responsibility for treatment and for reaching treatment goals on the patients since there's a big problem with compliance in this group of patients.
Read the detailed description
Consecutive patient sampling
- Conditions
- Hyperlipidemia
- Being tested
- Lipid Self Test
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid Self TestDevice
Self test for lipid levels, twice during study period
| Study group | Role | What they receive |
|---|---|---|
| Hyperlipidemic Patients | Not described Receives: Device: Lipid Self Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12
Participants with "Yes" response to a question which stated "The self-test have increased my motivation for taking my medication for hyperlipidemia?". The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test.
Measured: Month 12
Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12
Participants with "Yes" response to a question which stated "The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?".
Measured: Month 12
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8
Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".
Measured: Week 8
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6
Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".
Measured: Month 6
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12
Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".
Measured: Month 12
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Measured: Week 8
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Measured: Month 6
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Measured: Month 12
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8
Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Measured: Week 8
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6
Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Measured: Month 6
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12
Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperlipidemiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828945
- Sponsor's protocol ID
- A2581178
- Acronym
- COLL
- Status last verified
- Feb 2021
- First submitted
- 23 Jan 2009
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Non-Controlled, Open Study In Order To Document The Compliance With Treatment, According To Clinical Praxis And National Guidelines For Patients With Hyperlipidemia. COLL: Control Of Lipid Lowering
- ClinicalTrials.gov ID
- NCT00828945
- Acronym / sponsor ID
- COLL / A2581178
- Conditions
- Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Posted 22 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a prospective observational study.
Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin. Patients will be enrolled at a normal clinic visit and provided with a small box containing info about the disease, a LDL self-test and two questionnaires. They will test themselves for LDL at home between normal clinic visits (normally 12 months interval) and note their value. In the end of the study all patients will fill out a questionnaire with questions if the tests and info have raised their awareness of the disease as well if their motivation to be compliant has increased.
We want to look at the possibility to put more responsibility for treatment and for reaching treatment goals on the patients since there's a big problem with compliance in this group of patients.
Detailed description
Consecutive patient sampling
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperlipidemic Patients | – | Device: Lipid Self Test |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aged 18 years or older and able to understand and sign the informed consent form. • Patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular disease prescribed statin treatment according to clinical praxis and the recommendations set forth in the MPA national guideline for treatment of hyperlipidemia.
Key inclusion criteria (2 listed)
- Aged 18 years or older and able to understand and sign the informed consent form.
Key exclusion criteria (2 listed)
- Patients contraindicated for statin treatment according to market authorization for these drugs should be excluded from the study.
- Patients participating in other clinical trials or non-interventional studies.
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 |
|---|---|---|
| Lipid Self TestSelf test for lipid levels, twice during study period | Device | Hyperlipidemic Patients |
Primary outcome
Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12
Time frame: Month 12
Participants with "Yes" response to a question which stated "The self-test have increased my motivation for taking my medication for hyperlipidemia?". The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test.
Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12
Time frame: Month 12
Participants with "Yes" response to a question which stated "The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?".
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8
Time frame: Week 8
Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6
Time frame: Month 6
Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12
Time frame: Month 12
Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?".
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8
Time frame: Week 8
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6
Time frame: Month 6
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12
Time frame: Month 12
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8
Time frame: Week 8
Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6
Time frame: Month 6
Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12
Time frame: Month 12
Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in Sweden.
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 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Sweden. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12 (time frame: Month 12). The study lists 11 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 21 Feb 2021.