Actual Use Trial of Atorvastatin Calcium 10 mg

Hypercholesterolemia Clinical Trial

Official title:

A Multicenter, Actual Use Trial In A Simulated Over-the-counter Environment Of Atorvastatin Calcium 10 Mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964326
• Other study ID #: A2581189
• Status: Completed
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1311
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Atorvastatin calcium 10 mg
Atorvastatin calcium 10 mg tablet to be administered orally every day

Locations

Country	Name	City	State
United States	Duran Central Pharmacy	Albuquerque	New Mexico
United States	Sam's Regent Pharmacy	Albuquerque	New Mexico
United States	Catonsville Pharmacy	Baltimore	Maryland
United States	Family Prescription Center	Bethlehem	Pennsylvania
United States	Mountain West Apothecary	Bountiful	Utah
United States	Sutton Family Pharmacy	Dalton	Georgia
United States	Kemper Drug	Elk River	Minnesota
United States	Jim's Pharmacy	Enumclaw	Washington
United States	Garden Drug	Fort Lauderdale	Florida
United States	Goodrich Pharmacy	Fridley	Minnesota
United States	Wynn's Pharmacy Inc.	Griffin	Georgia
United States	T.B. Bond Pharmacy	Hillsboro	Texas
United States	Robert's Discount Pharmacy	Hoover	Alabama
United States	Inwood Pharmacy	Houston	Texas
United States	Albers' Medical Pharmacy	Kansas City	Missouri
United States	Ostrom Drugs	Kenmore	Washington
United States	Bi-Rite Quality Pharmacies	La Habra	California
United States	Pharmacy at the Pig	McCalla	Alabama
United States	Community Clinical Pharmacy	Mesa	Arizona
United States	Texas Road Pharmacy	Monroe	New Jersey
United States	Montpelier Pharmacy, Inc.	Montpelier	Virginia
United States	Northfield Pharmacy	Northfield	Minnesota
United States	Pill Box Pharmacy and Medical Supply	Pembroke Pines	Florida
United States	Melrose Pharmacy	Phoenix	Arizona
United States	Pinson Discount Drugs	Pinson	Alabama
United States	Parkview Compounding Pharmacy	Rancho Cucamonga	California
United States	Lafayette Pharmacy	Richmond	Virginia
United States	Summerfield Pharmacy	Riverview	Florida
United States	Cub Pharmacy	Rosemount	Minnesota
United States	Ridgeview Pharmacy	Roy	Utah
United States	Goodrich Pharmacy	Saint Francis	Minnesota
United States	The Apothecary Shoppe	Salt Lake City	Utah
United States	The Medicine Center	Salt Lake City	Utah
United States	Countryside Pharmacy	Savannah	Missouri
United States	Katterman's Sand Point Professional Pharmacy	Seattle	Washington
United States	Brick Street Pharmacy	Tyler	Texas
United States	Family Plaza Pharmacy	West Jordan	Utah

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 up to Week 26
Primary	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.	Day 1 up to Week 26
Secondary	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.	Day 1 up to Week 26
Secondary	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.	Day 1 up to Week 26

External Links

•   To obtain contact information for a study center near you, click here.