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Compliance With Treatment For Patients With Hyperlipidemia

Last updated on November 12, 2019

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Study Location
Pfizer Investigational Site
Akersberga, , 184 27 Sweden
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hyperlipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00828945
Pfizer
Completed
Compliance With Treatment For Patients With Hyperlipidemia

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Descriptive Information
Brief TitleCompliance With Treatment For Patients With Hyperlipidemia
Official TitleA 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
Brief 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. 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 DescriptionConsecutive patient sampling
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
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.

ConditionHyperlipidemia
InterventionDevice: Lipid Self Test
Self test for lipid levels, twice during study period
Study Groups/CohortsHyperlipidemic Patients
Intervention: Device: Lipid Self Test
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: July 28, 2011)
259
Original Estimated Enrollment
 (submitted: January 23, 2009)
300
Actual Study Completion DateMarch 2011
Actual Primary Completion DateMarch 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesSweden
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00828945
Other Study ID NumbersA2581178
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2012

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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