Actual Use Trial of Atorvastatin Calcium 10 mg

NCT01964326 | Completed Phase 3 Results

• 1 other identifier: A2581189
• Study Type: interventional
• Target: 1,311
• Locations: 1 country
• Sites: 37

Brief Summary

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

Conditions

Hypercholesterolemia

Keywords

atorvastatin; Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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

  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

  Day 1 up to Week 26

Study Arms (1)

Atorvastatin calcium 10 mg

EXPERIMENTAL

Drug: Atorvastatin calcium 10 mg

Interventions

Atorvastatin calcium 10 mg DRUG

Atorvastatin calcium 10 mg tablet to be administered orally every day

Atorvastatin calcium 10 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age (19 in Alabama).
• Provide written informed consent.
• Never participated in a study about cholesterol medicines.

You may not qualify if:

• Females subjects who are pregnant or breastfeeding.
• Subjects with active liver disease.
• Subjects taking cyclosporine.
• Subjects with a known allergy to atorvastatin calcium.

Sponsors & Collaborators

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

Study Sites (37)

Robert's Discount Pharmacy

Hoover, Alabama, 35226, United States

Location

Pharmacy at the Pig

McCalla, Alabama, 35111, United States

Location

Pinson Discount Drugs

Pinson, Alabama, 35126, United States

Location

Community Clinical Pharmacy

Mesa, Arizona, 85202, United States

Location

Melrose Pharmacy

Phoenix, Arizona, 85013, United States

Location

Bi-Rite Quality Pharmacies

La Habra, California, 90631, United States

Location

Parkview Compounding Pharmacy

Rancho Cucamonga, California, 91730, United States

Location

Garden Drug

Fort Lauderdale, Florida, 33309, United States

Location

Pill Box Pharmacy and Medical Supply

Pembroke Pines, Florida, 33026, United States

Location

Summerfield Pharmacy

Riverview, Florida, 33569, United States

Location

Sutton Family Pharmacy

Dalton, Georgia, 30721, United States

Location

Wynn's Pharmacy Inc.

Griffin, Georgia, 30224, United States

Location

Catonsville Pharmacy

Baltimore, Maryland, 21228, United States

Location

Kemper Drug

Elk River, Minnesota, 55330, United States

Location

Goodrich Pharmacy

Fridley, Minnesota, 55432, United States

Location

Northfield Pharmacy

Northfield, Minnesota, 55057, United States

Location

Cub Pharmacy

Rosemount, Minnesota, 55068, United States

Location

Goodrich Pharmacy

Saint Francis, Minnesota, 55070, United States

Location

Albers' Medical Pharmacy

Kansas City, Missouri, 64111, United States

Location

Countryside Pharmacy

Savannah, Missouri, 64485, United States

Location

Texas Road Pharmacy

Monroe, New Jersey, 08831, United States

Location

Duran Central Pharmacy

Albuquerque, New Mexico, 87104, United States

Location

Sam's Regent Pharmacy

Albuquerque, New Mexico, 87109, United States

Location

Family Prescription Center

Bethlehem, Pennsylvania, 18015, United States

Location

T.B. Bond Pharmacy

Hillsboro, Texas, 76645, United States

Location

Inwood Pharmacy

Houston, Texas, 77070, United States

Location

Brick Street Pharmacy

Tyler, Texas, 75701, United States

Location

Mountain West Apothecary

Bountiful, Utah, 84010, United States

Location

Ridgeview Pharmacy

Roy, Utah, 84067, United States

Location

The Apothecary Shoppe

Salt Lake City, Utah, 84102, United States

Location

The Medicine Center

Salt Lake City, Utah, 84121, United States

Location

Family Plaza Pharmacy

West Jordan, Utah, 84088, United States

Location

Montpelier Pharmacy, Inc.

Montpelier, Virginia, 23192, United States

Location

Lafayette Pharmacy

Richmond, Virginia, 23221, United States

Location

Jim's Pharmacy

Enumclaw, Washington, 98022, United States

Location

Ostrom Drugs

Kenmore, Washington, 98028, United States

Location

Katterman's Sand Point Professional Pharmacy

Seattle, Washington, 98105, United States

Location

Related Links

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

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1--800--718--1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 17, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 21, 2021
• Results First Posted: January 27, 2016

Record last verified: 2021-02

Locations

US (37)