Actual Use Trial of Atorvastatin Calcium 10 mg

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01964326
First received: October 14, 2013
Last updated: September 10, 2014
Last verified: September 2014

October 14, 2013
September 10, 2014
October 2013
December 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01964326 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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
Intervention Model: Single Group Assignment
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.
 
Active, not recruiting
1200
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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01964326
A2581189
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

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