Actual Use Trial of Atorvastatin Calcium 10 mg

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01964326
First received: October 14, 2013
Last updated: April 11, 2014
Last verified: April 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
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: April 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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014