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Actual Use Trial of Atorvastatin Calcium 10 mg

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin calcium 10 mg
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring atorvastatin, Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Robert's Discount Pharmacy
  • Pharmacy at the Pig
  • Pinson Discount Drugs
  • Community Clinical Pharmacy
  • Melrose Pharmacy
  • Bi-Rite Quality Pharmacies
  • Parkview Compounding Pharmacy
  • Garden Drug
  • Pill Box Pharmacy and Medical Supply
  • Summerfield Pharmacy
  • Sutton Family Pharmacy
  • Wynn's Pharmacy Inc.
  • Catonsville Pharmacy
  • Kemper Drug
  • Goodrich Pharmacy
  • Northfield Pharmacy
  • Cub Pharmacy
  • Goodrich Pharmacy
  • Albers' Medical Pharmacy
  • Countryside Pharmacy
  • Texas Road Pharmacy
  • Duran Central Pharmacy
  • Sam's Regent Pharmacy
  • Family Prescription Center
  • T.B. Bond Pharmacy
  • Inwood Pharmacy
  • Brick Street Pharmacy
  • Mountain West Apothecary
  • Ridgeview Pharmacy
  • The Apothecary Shoppe
  • The Medicine Center
  • Family Plaza Pharmacy
  • Montpelier Pharmacy, Inc.
  • Lafayette Pharmacy
  • Jim's Pharmacy
  • Ostrom Drugs
  • Katterman's Sand Point Professional Pharmacy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atorvastatin calcium 10 mg

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level
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
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.

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
October 14, 2013
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01964326
Brief Title
Actual Use Trial of Atorvastatin Calcium 10 mg
Official Title
A Multicenter, Actual Use Trial In A Simulated Over-the-counter Environment Of Atorvastatin Calcium 10 Mg
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
atorvastatin, Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
N/A
Enrollment
1311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin calcium 10 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atorvastatin calcium 10 mg
Intervention Description
Atorvastatin calcium 10 mg tablet to be administered orally every day
Primary Outcome Measure Information:
Title
Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level
Description
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.
Time Frame
Day 1 up to Week 26
Title
Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results
Description
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.
Time Frame
Day 1 up to Week 26
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 1 up to Week 26
Title
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
Description
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.
Time Frame
Day 1 up to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Robert's Discount Pharmacy
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Facility Name
Pharmacy at the Pig
City
McCalla
State/Province
Alabama
ZIP/Postal Code
35111
Country
United States
Facility Name
Pinson Discount Drugs
City
Pinson
State/Province
Alabama
ZIP/Postal Code
35126
Country
United States
Facility Name
Community Clinical Pharmacy
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Melrose Pharmacy
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Bi-Rite Quality Pharmacies
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
Parkview Compounding Pharmacy
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Garden Drug
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Pill Box Pharmacy and Medical Supply
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Summerfield Pharmacy
City
Riverview
State/Province
Florida
ZIP/Postal Code
33569
Country
United States
Facility Name
Sutton Family Pharmacy
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30721
Country
United States
Facility Name
Wynn's Pharmacy Inc.
City
Griffin
State/Province
Georgia
ZIP/Postal Code
30224
Country
United States
Facility Name
Catonsville Pharmacy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Kemper Drug
City
Elk River
State/Province
Minnesota
ZIP/Postal Code
55330
Country
United States
Facility Name
Goodrich Pharmacy
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Northfield Pharmacy
City
Northfield
State/Province
Minnesota
ZIP/Postal Code
55057
Country
United States
Facility Name
Cub Pharmacy
City
Rosemount
State/Province
Minnesota
ZIP/Postal Code
55068
Country
United States
Facility Name
Goodrich Pharmacy
City
Saint Francis
State/Province
Minnesota
ZIP/Postal Code
55070
Country
United States
Facility Name
Albers' Medical Pharmacy
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Countryside Pharmacy
City
Savannah
State/Province
Missouri
ZIP/Postal Code
64485
Country
United States
Facility Name
Texas Road Pharmacy
City
Monroe
State/Province
New Jersey
ZIP/Postal Code
08831
Country
United States
Facility Name
Duran Central Pharmacy
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87104
Country
United States
Facility Name
Sam's Regent Pharmacy
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Family Prescription Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
T.B. Bond Pharmacy
City
Hillsboro
State/Province
Texas
ZIP/Postal Code
76645
Country
United States
Facility Name
Inwood Pharmacy
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Brick Street Pharmacy
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Mountain West Apothecary
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Ridgeview Pharmacy
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
The Apothecary Shoppe
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
The Medicine Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Family Plaza Pharmacy
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Montpelier Pharmacy, Inc.
City
Montpelier
State/Province
Virginia
ZIP/Postal Code
23192
Country
United States
Facility Name
Lafayette Pharmacy
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23221
Country
United States
Facility Name
Jim's Pharmacy
City
Enumclaw
State/Province
Washington
ZIP/Postal Code
98022
Country
United States
Facility Name
Ostrom Drugs
City
Kenmore
State/Province
Washington
ZIP/Postal Code
98028
Country
United States
Facility Name
Katterman's Sand Point Professional Pharmacy
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581189&StudyName=Actual%20Use%20Trial%20of%20Atorvastatin%20Calcium%2010%20mg%20
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Actual Use Trial of Atorvastatin Calcium 10 mg

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