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Trial record 1 of 1 for:    NCT00673660
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Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels

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ClinicalTrials.gov Identifier: NCT00673660
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : November 4, 2010
Last Update Posted : November 17, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date May 1, 2008
First Posted Date May 7, 2008
Results First Submitted Date October 6, 2010
Results First Posted Date November 4, 2010
Last Update Posted Date November 17, 2010
Study Start Date October 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2010)
Percentage of Participants Who Were Compliant With Statin Treatment [ Time Frame: Month 12 ]
The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used.
Original Primary Outcome Measures
 (submitted: May 1, 2008)
To measure the compliance of patients administarting statin treatment [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT00673660 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 6, 2010)
  • Available Lipid Profiles of Compliant and Non-compliant Participants [ Time Frame: Month 12 ]
    Available laboratory measurements of participants were recorded in CRFs.
  • Number of Participants With Reasons of Compliance to Statin Treatment [ Time Frame: Month 12 ]
    Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded.
  • Number of Participants With Reasons of Non-compliance to Statin Treatment [ Time Frame: Month 12 ]
    Participants were called for a final visit and reasons for non-compliance were recorded.
Original Secondary Outcome Measures
 (submitted: May 1, 2008)
  • Observing reasons of compliance or non-compliance to statin treatment [ Time Frame: 12 months ]
  • Observing differences of Lipid profiles between compliant and non-compliant patients to statin treatment [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels
Official Title Assessment Of Statin Treatment Compliance In Dyslipidemia Patients: An Observational Study
Brief Summary The purpose of the study is to show the compliance rates of the patients to statin treatment and the reasons of non-compliance.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
No biospecimen is retained
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with dyslipidemia and taking or planning to take statin treatment. Patients living in the same city of the study center. Patients aged 18 years old and over.
Condition Dyslipidemia
Intervention Behavioral: Patient Compliance
Compliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months.
Study Groups/Cohorts Statins
Patients with dyslipidemia who are taking or planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin or generics).
Intervention: Behavioral: Patient Compliance
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 Status Completed
Actual Enrollment
 (submitted: December 11, 2009)
375
Original Estimated Enrollment
 (submitted: May 1, 2008)
670
Actual Study Completion Date October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients diagnosed with dyslipidemia and taking or planning to take statin treatment.
  • Patients living in the same city of the study center. o Patients aged 18 years and over.

Exclusion Criteria:

  • Patients with severe systemic disease
  • Patients with alcohol and drug addiction and/or mental disease
  • Patients nursing or pregnant, or planning to get pregnant during the study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT00673660
Other Study ID Numbers A2581156
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2009