Actual Use Trial of Atorvastatin Calcium 10 mg

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1311

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hoover, Alabama, United States, 35226
        • Robert's Discount Pharmacy
      • McCalla, Alabama, United States, 35111
        • Pharmacy at the Pig
      • Pinson, Alabama, United States, 35126
        • Pinson Discount Drugs
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Community Clinical Pharmacy
      • Phoenix, Arizona, United States, 85013
        • Melrose Pharmacy
    • California
      • La Habra, California, United States, 90631
        • Bi-Rite Quality Pharmacies
      • Rancho Cucamonga, California, United States, 91730
        • Parkview Compounding Pharmacy
    • Florida
      • Fort Lauderdale, Florida, United States, 33309
        • Garden Drug
      • Pembroke Pines, Florida, United States, 33026
        • Pill Box Pharmacy and Medical Supply
      • Riverview, Florida, United States, 33569
        • Summerfield Pharmacy
    • Georgia
      • Dalton, Georgia, United States, 30721
        • Sutton Family Pharmacy
      • Griffin, Georgia, United States, 30224
        • Wynn's Pharmacy Inc.
    • Maryland
      • Baltimore, Maryland, United States, 21228
        • Catonsville Pharmacy
    • Minnesota
      • Elk River, Minnesota, United States, 55330
        • Kemper Drug
      • Fridley, Minnesota, United States, 55432
        • Goodrich Pharmacy
      • Northfield, Minnesota, United States, 55057
        • Northfield Pharmacy
      • Rosemount, Minnesota, United States, 55068
        • Cub Pharmacy
      • Saint Francis, Minnesota, United States, 55070
        • Goodrich Pharmacy
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Albers' Medical Pharmacy
      • Savannah, Missouri, United States, 64485
        • Countryside Pharmacy
    • New Jersey
      • Monroe, New Jersey, United States, 08831
        • Texas Road Pharmacy
    • New Mexico
      • Albuquerque, New Mexico, United States, 87104
        • Duran Central Pharmacy
      • Albuquerque, New Mexico, United States, 87109
        • Sam's Regent Pharmacy
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Family Prescription Center
    • Texas
      • Hillsboro, Texas, United States, 76645
        • T.B. Bond Pharmacy
      • Houston, Texas, United States, 77070
        • Inwood Pharmacy
      • Tyler, Texas, United States, 75701
        • Brick Street Pharmacy
    • Utah
      • Bountiful, Utah, United States, 84010
        • Mountain West Apothecary
      • Roy, Utah, United States, 84067
        • Ridgeview Pharmacy
      • Salt Lake City, Utah, United States, 84102
        • The Apothecary Shoppe
      • Salt Lake City, Utah, United States, 84121
        • The Medicine Center
      • West Jordan, Utah, United States, 84088
        • Family Plaza Pharmacy
    • Virginia
      • Montpelier, Virginia, United States, 23192
        • Montpelier Pharmacy, Inc.
      • Richmond, Virginia, United States, 23221
        • Lafayette Pharmacy
    • Washington
      • Enumclaw, Washington, United States, 98022
        • Jim's Pharmacy
      • Kenmore, Washington, United States, 98028
        • Ostrom Drugs
      • Seattle, Washington, United States, 98105
        • Katterman's Sand Point Professional Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atorvastatin calcium 10 mg
Drug: Atorvastatin calcium 10 mg
Atorvastatin calcium 10 mg tablet to be administered orally every day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 up to Week 26
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.
Day 1 up to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 up to Week 26
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.
Day 1 up to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

October 14, 2013

First Posted (Estimate)

October 17, 2013

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2581189

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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