Text Size

Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00673660
First received: May 1, 2008
Last updated: November 5, 2010
Last verified: December 2009
History of Changes
Results First Received: October 6, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Dyslipidemia
Intervention: Behavioral: Patient Compliance

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was an observational study evaluating compliance to statin treatment in participants with dyslipidemia. Data available at each visit was recorded in case report forms (CRFs). No laboratory measurements were performed. The gender of 2 subjects was not recorded.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Statins Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).

Participant Flow:   Overall Study
    Statins  
STARTED     375  
COMPLETED     268  
NOT COMPLETED     107  
Lost to Follow-up                 107  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Statins Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).

Baseline Measures
    Statins  
Number of Participants  
[units: participants]
 		  375  
Age  
[units: years]
Mean ± Standard Deviation 		  59.7  ± 10.6  
Gender, Customized  
[units: participants]
 		 
Female     186  
Male     187  
Unknown     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Were Compliant With Statin Treatment   [ Time Frame: Month 12 ]
  Show Outcome Measure 1

2.  Secondary:   Available Lipid Profiles of Compliant and Non-compliant Participants   [ Time Frame: Month 12 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Reasons of Compliance to Statin Treatment   [ Time Frame: Month 12 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Reasons of Non-compliance to Statin Treatment   [ Time Frame: Month 12 ]
  Show Outcome Measure 4


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Statins at Visit 2 Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
Statins at Visit 3 Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
Statins at Visit 4 Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
Statins Visit 5 Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).

Other Adverse Events
    Statins at Visit 2     Statins at Visit 3     Statins at Visit 4     Statins Visit 5  
Total, other (not including serious) adverse events          
# participants affected / at risk     5/153     4/76     4/44     6/268  
General disorders          
Headache † 1        
# participants affected / at risk     1/153 (0.65%)     0/76 (0.00%)     0/44 (0.00%)     1/268 (0.37%)  
Back pain † 1        
# participants affected / at risk     1/153 (0.65%)     1/76 (1.32%)     1/44 (2.27%)     0/268 (0.00%)  
Allergic reaction † 1        
# participants affected / at risk     1/153 (0.65%)     1/76 (1.32%)     0/44 (0.00%)     0/268 (0.00%)  
Arthralgia † 1        
# participants affected / at risk     1/153 (0.65%)     1/76 (1.32%)     0/44 (0.00%)     0/268 (0.00%)  
Myalgia † 1        
# participants affected / at risk     0/153 (0.00%)     0/76 (0.00%)     0/44 (0.00%)     1/268 (0.37%)  
Dizziness † 1        
# participants affected / at risk     1/153 (0.65%)     0/76 (0.00%)     0/44 (0.00%)     1/268 (0.37%)  
Constipation † 1        
# participants affected / at risk     0/153 (0.00%)     0/76 (0.00%)     0/44 (0.00%)     1/268 (0.37%)  
Dyspepsia † 1        
# participants affected / at risk     0/153 (0.00%)     0/76 (0.00%)     1/44 (2.27%)     0/268 (0.00%)  
Nausea † 1        
# participants affected / at risk     2/153 (1.31%)     0/76 (0.00%)     0/44 (0.00%)     0/268 (0.00%)  
Gas † 1        
# participants affected / at risk     2/153 (1.31%)     0/76 (0.00%)     0/44 (0.00%)     0/268 (0.00%)  
Pharyngitis † 1        
# participants affected / at risk     0/153 (0.00%)     0/76 (0.00%)     1/44 (2.27%)     0/268 (0.00%)  
Elevated liver enzyme levels † 1        
# participants affected / at risk     1/153 (0.65%)     2/76 (2.63%)     1/44 (2.27%)     1/268 (0.37%)  
Rash on hands † 1        
# participants affected / at risk     0/153 (0.00%)     1/76 (1.32%)     0/44 (0.00%)     0/268 (0.00%)  
Cough † 1        
# participants affected / at risk     0/153 (0.00%)     0/76 (0.00%)     1/44 (2.27%)     0/268 (0.00%)  
Abdominal discomfort † 1        
# participants affected / at risk     0/153 (0.00%)     0/76 (0.00%)     1/44 (2.27%)     0/268 (0.00%)  
Visual impairment † 1        
# participants affected / at risk     0/153 (0.00%)     0/76 (0.00%)     0/44 (0.00%)     1/268 (0.37%)  
Renal failure † 1        
# participants affected / at risk     0/153 (0.00%)     0/76 (0.00%)     0/44 (0.00%)     1/268 (0.37%)  
Vertigo † 1        
# participants affected / at risk     0/153 (0.00%)     0/76 (0.00%)     0/44 (0.00%)     1/268 (0.37%)  
Other † 1        
# participants affected / at risk     3/153 (1.96%)     0/76 (0.00%)     0/44 (0.00%)     0/268 (0.00%)  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA v11.1



  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The registered endpoint - observing reasons of compliance or non-compliance to statin treatment - was separated into outcome measure 6 and 7 because observing reasons for compliance with statin treatment were not collected or analyzed.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00673660     History of Changes
Other Study ID Numbers: A2581156
Study First Received: May 1, 2008
Results First Received: October 6, 2010
Last Updated: November 5, 2010
Health Authority: Turkey: Ministry of Health