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

October 14, 2013
April 18, 2016
October 2013
December 2014   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Percentage of subjects who comply with the direction to check their low-density lipoprotein cholesterol (LDL C) level [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Percentage of subjects who, after checking their LDL C level, take the appropriate action based on their test results.
Complete list of historical versions of study NCT01964326 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
Not Provided
Not Provided
 
Actual Use Trial of Atorvastatin Calcium 10 mg
A Multicenter, Actual Use Trial In A Simulated Over-the-counter Environment Of Atorvastatin Calcium 10 Mg
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Hypercholesterolemia
Drug: Atorvastatin calcium 10 mg
Atorvastatin calcium 10 mg tablet to be administered orally every day
Experimental: Atorvastatin calcium 10 mg
Intervention: Drug: Atorvastatin calcium 10 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1311
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01964326
A2581189
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2016

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