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Trial record 1 of 1 for:    NCT01964326
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Actual Use Trial of Atorvastatin Calcium 10 mg

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01964326
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : January 27, 2016
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 14, 2013
First Posted Date  ICMJE October 17, 2013
Results First Submitted Date  ICMJE December 18, 2015
Results First Posted Date  ICMJE January 27, 2016
Last Update Posted Date May 18, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
  • 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 ]
    Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants had their LDL-C checked between Weeks 4 and 12. The behavior was considered acceptable if participants had their LDL-C checked between Weeks 2 and 3 (before Week 4) or between Weeks 13 (after Week 12) and 26 or if participants were instructed by a physician that an LDL-C test was not needed.
  • Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results [ Time Frame: Day 1 up to Week 26 ]
    Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants self-reported an LDL-C level below 130 milligram per deciliter (mg/dL) or normal, or low and decided to continue with atorvastatin OTC or if participants self-reported an LDL-C below 130 mg/dL, or normal, or low but stopped the use because of new conditions preventing them from continuing use. The behavior was considered acceptable if participants self-report LDL-C level between 130 and 135 mg/dL and continued to use atorvastatin OTC without contacting a physician or other health care practitioner or if participants self-reported LDL-C greater than or equal to (>=) 130 mg/dL('borderline high' or 'high' LDL-C), and contacted a physician after getting the LDL-C test results.
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2013)
  • Percentage of subjects who comply with the direction to check their low-density lipoprotein cholesterol (LDL C) level [ Time Frame: 26 weeks ]
    Percentage of subjects who, after starting the use of atorvastatin 10 mg (OTC), comply with the direction to check their low-density lipoprotein cholesterol (LDL C) level
  • Percentage of subjects who, after checking their LDL C level, take the appropriate action based on their test results [ Time Frame: 26 weeks ]
    Percentage of subjects who, after checking their LDL C level, take the appropriate action based on their test results.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
  • 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 ]
    Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. 'Ask a doctor or pharmacist before use' medication included human immunodeficiency virus (HIV) medicine, digoxin, telaprevir, rifampin, colchicine, or oral contraceptives. The behavior of the participants was considered correct if participants asked a doctor or pharmacist before use. The behavior was considered acceptable if participants contacted a doctor or pharmacist within 7 days of initiating therapy.
  • 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 ]
    Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The "Stop use and ask a doctor" symptoms included: (a) unexplained muscle pain or weakness or tenderness, (b) unusual fatigue, (c) loss of appetite (d) upper belly pain (e) dark-colored urine or (f) yellowing of the whites of eyes or skin. The behavior of the participants was considered correct if participants stopped use and contacted a doctor within 7 days after the event (symptom development).The behavior was considered acceptable if participants either stopped use or contacted a doctor (but did not do both) within the 7 days' timeframe.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2013)
  • Proportion of subjects currently taking an "Ask a doctor or pharmacist before use" medication who follow the directions and contact a doctor or pharmacist before using the atorvastatin OTC [ Time Frame: 1 week ]
    Proportion of subjects currently taking an "Ask a doctor or pharmacist before use" medication who follow the directions and contact a doctor or pharmacist before using the atorvastatin OTC. These are subjects who are taking human immunodeficiency virus (HIV) medicine, digoxin, telaprevir, rifampin, colchicine, or oral contraceptives
  • Proportion of subjects who stop study medication use and ask a doctor if they experience any of the labeled "Stop use and ask a doctor" symptoms [ Time Frame: 1 week ]
    Proportion of subjects who stop study medication use and ask a doctor if they experience any of the labeled "Stop use and ask a doctor" symptoms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Actual Use Trial of Atorvastatin Calcium 10 mg
Official Title  ICMJE A Multicenter, Actual Use Trial In A Simulated Over-the-counter Environment Of Atorvastatin Calcium 10 Mg
Brief Summary The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE Drug: Atorvastatin calcium 10 mg
Atorvastatin calcium 10 mg tablet to be administered orally every day
Study Arms  ICMJE Experimental: Atorvastatin calcium 10 mg
Intervention: Drug: Atorvastatin calcium 10 mg
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2016)
1311
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2013)
1200
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years of age (19 in Alabama).
  • Provide written informed consent.
  • Never participated in a study about cholesterol medicines.

Exclusion Criteria:

  • Females subjects who are pregnant or breastfeeding.
  • Subjects with active liver disease.
  • Subjects taking cyclosporine.
  • Subjects with a known allergy to atorvastatin calcium.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01964326
Other Study ID Numbers  ICMJE A2581189
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP