Compliance With Treatment For Patients With Hyperlipidemia

NCT00828945 | Completed Results

• 1 other identifier: A2581178
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 17

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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (11)

• 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.

  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?".

  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?".

  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?".

  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?".

  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.

  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.

  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.

  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.

  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.

  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.

  Month 12

Study Arms (1)

Hyperlipidemic Patients

Device: Lipid Self Test

Interventions

Lipid Self Test DEVICE

Self test for lipid levels, twice during study period

Hyperlipidemic Patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (17)

Pfizer Investigational Site

Åkersberga, 184 27, Sweden

Location

Pfizer Investigational Site

Forshaga, 667 32, Sweden

Location

Pfizer Investigational Site

Gothenburg, 405 30, Sweden

Location

Pfizer Investigational Site

Gothenburg, 415 10, Sweden

Location

Pfizer Investigational Site

Gothenburg, 41665, Sweden

Location

Pfizer Investigational Site

Höganäs, 263 36, Sweden

Location

Pfizer Investigational Site

Jönköping, 553 16, Sweden

Location

Pfizer Investigational Site

Lessebo, 360 50, Sweden

Location

Pfizer Investigational Site

Lilla Edet, 46330, Sweden

Location

Pfizer Investigational Site

Limhamn, 216 43, Sweden

Location

Pfizer Investigational Site

Malmo, 211 20, Sweden

Location

Pfizer Investigational Site

Oviken, 830 24, Sweden

Location

Pfizer Investigational Site

Partille, 433 34, Sweden

Location

Pfizer Investigational Site

Stockholm, 111 35, Sweden

Location

Pfizer Investigational Site

Täby, 183 30, Sweden

Location

Pfizer Investigational Site

Trollhättan, 461 53, Sweden

Location

Pfizer Investigational Site

Västerås, 722 11, Sweden

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 26, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 21, 2021
• Results First Posted: March 22, 2012

Record last verified: 2021-02

Locations

SE (17)