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Actual Use Trial of Atorvastatin Calcium 10 mg

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01964326
First received: October 14, 2013
Last updated: April 18, 2016
Last verified: April 2016
Results First Received: December 18, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Intervention: Drug: Atorvastatin calcium 10 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened by phone, then referred to their participating retail pharmacy site for a scheduled face-to-face interview, after which they were given an empty atorvastatin(Lipitor) over-the-counter(OTC) package to review the information on the outside of the entire package,after which decision was made to purchase the medicine by them.

Reporting Groups
  Description
Atorvastatin Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.

Participant Flow:   Overall Study
    Atorvastatin  
STARTED     1311  
COMPLETED     1014  
NOT COMPLETED     297  
Adverse Event                 48  
Death                 2  
Protocol Violation                 4  
Lost to Follow-up                 88  
Withdrawal by Subject                 87  
Pregnancy                 1  
No Longer Meets Eligibility Criteria                 1  
Physician Decision                 55  
Investigator Discretion                 1  
Unspecified                 9  
Did not meet eligibility criteria                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Users/Safety set included all participants reported taking at least 1 dose of study medication or had at least 1 dosing record available or responded 'yes' to the question 'have you started taking Lipitor OTC' in any phone interview, or contacted the study site in any other manner and indicated the use of study product.

Reporting Groups
  Description
Atorvastatin Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.

Baseline Measures
    Atorvastatin  
Number of Participants  
[units: participants]
  1234  
Age  
[units: Years]
Mean (Standard Deviation)
  57.8  (11.5)  
Gender  
[units: Participants]
 
Female     593  
Male     641  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level   [ Time Frame: Day 1 up to Week 26 ]

2.  Primary:   Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results   [ Time Frame: Day 1 up to Week 26 ]

3.  Secondary:   Percentage of Participants Taking an "Ask a Doctor or Pharmacist Before Use" Medication Who Followed the Labeling and Contacted a Doctor or Pharmacist Before Using Study Medication   [ Time Frame: Day 1 up to Week 26 ]

4.  Secondary:   Percentage of Participants Who Stopped Study Medication Use and Asked a Doctor if They Experienced Any of the Labeled "Stop Use and Ask a Doctor" Symptoms   [ Time Frame: Day 1 up to Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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.


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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01964326     History of Changes
Other Study ID Numbers: A2581189
Study First Received: October 14, 2013
Results First Received: December 18, 2015
Last Updated: April 18, 2016
Health Authority: United States: Food and Drug Administration