Clinical trial NCT01964326: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: atorvastatin
Hypercholesterolemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 1311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level
timeFrame: Day 1 up to Week 26
measure: Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results
timeFrame: Day 1 up to Week 26
Secondary outcomes:
measure: 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
timeFrame: Day 1 up to Week 26
measure: 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
timeFrame: Day 1 up to Week 26
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Robert's Discount Pharmacy
state: Alabama
city: McCalla
country: United States
facility: Pharmacy at the Pig
state: Alabama
city: Pinson
country: United States
facility: Pinson Discount Drugs
state: Alabama
city: Mesa
country: United States
facility: Community Clinical Pharmacy
state: Arizona
city: Phoenix
country: United States
facility: Melrose Pharmacy
state: Arizona
city: La Habra
country: United States
facility: Bi-Rite Quality Pharmacies
state: California
city: Rancho Cucamonga
country: United States
facility: Parkview Compounding Pharmacy
state: California
city: Fort Lauderdale
country: United States
facility: Garden Drug
state: Florida
city: Pembroke Pines
country: United States
facility: Pill Box Pharmacy and Medical Supply
state: Florida
city: Riverview
country: United States
facility: Summerfield Pharmacy
state: Florida
city: Dalton
country: United States
facility: Sutton Family Pharmacy
state: Georgia
city: Griffin
country: United States
facility: Wynn's Pharmacy Inc.
state: Georgia
city: Baltimore
country: United States
facility: Catonsville Pharmacy
state: Maryland
city: Elk River
country: United States
facility: Kemper Drug
state: Minnesota
city: Fridley
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Northfield
country: United States
facility: Northfield Pharmacy
state: Minnesota
city: Rosemount
country: United States
facility: Cub Pharmacy
state: Minnesota
city: Saint Francis
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Kansas City
country: United States
facility: Albers' Medical Pharmacy
state: Missouri
city: Savannah
country: United States
facility: Countryside Pharmacy
state: Missouri
city: Monroe
country: United States
facility: Texas Road Pharmacy
state: New Jersey
city: Albuquerque
country: United States
facility: Duran Central Pharmacy
state: New Mexico
city: Albuquerque
country: United States
facility: Sam's Regent Pharmacy
state: New Mexico
city: Bethlehem
country: United States
facility: Family Prescription Center
state: Pennsylvania
city: Hillsboro
country: United States
facility: T.B. Bond Pharmacy
state: Texas
city: Houston
country: United States
facility: Inwood Pharmacy
state: Texas
city: Tyler
country: United States
facility: Brick Street Pharmacy
state: Texas
city: Bountiful
country: United States
facility: Mountain West Apothecary
state: Utah
city: Roy
country: United States
facility: Ridgeview Pharmacy
state: Utah
city: Salt Lake City
country: United States
facility: The Apothecary Shoppe
state: Utah
city: Salt Lake City
country: United States
facility: The Medicine Center
state: Utah
city: West Jordan
country: United States
facility: Family Plaza Pharmacy
state: Utah
city: Montpelier
country: United States
facility: Montpelier Pharmacy, Inc.
state: Virginia
city: Richmond
country: United States
facility: Lafayette Pharmacy
state: Virginia
city: Enumclaw
country: United States
facility: Jim's Pharmacy
state: Washington
city: Kenmore
country: United States
facility: Ostrom Drugs
state: Washington
city: Seattle
country: United States
facility: Katterman's Sand Point Professional Pharmacy
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: