Actual Use Trial of Atorvastatin Calcium 10 mg

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01964326
First received: October 14, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.


Condition Intervention Phase
Hypercholesterolemia
Drug: Atorvastatin calcium 10 mg
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Actual Use Trial In A Simulated Over-the-Counter Environment Of Atorvastatin Calcium 10 mg

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1200
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin calcium 10 mg Drug: Atorvastatin calcium 10 mg
Atorvastatin calcium 10 mg tablet to be administered orally every day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964326

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 38 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01964326     History of Changes
Other Study ID Numbers: A2581189
Study First Received: October 14, 2013
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
atorvastatin
Hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Atorvastatin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014