Actual Use Trial of Atorvastatin Calcium 10 mg

NCT ID: NCT01964326

Last Updated: 2021-02-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

NA

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atorvastatin calcium 10 mg

Group Type EXPERIMENTAL

Atorvastatin calcium 10 mg

Intervention Type DRUG

Atorvastatin calcium 10 mg tablet to be administered orally every day

Interventions

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Atorvastatin calcium 10 mg

Atorvastatin calcium 10 mg tablet to be administered orally every day

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Robert's Discount Pharmacy

Hoover, Alabama, United States

Site Status

Pharmacy at the Pig

McCalla, Alabama, United States

Site Status

Pinson Discount Drugs

Pinson, Alabama, United States

Site Status

Community Clinical Pharmacy

Mesa, Arizona, United States

Site Status

Melrose Pharmacy

Phoenix, Arizona, United States

Site Status

Bi-Rite Quality Pharmacies

La Habra, California, United States

Site Status

Parkview Compounding Pharmacy

Rancho Cucamonga, California, United States

Site Status

Garden Drug

Fort Lauderdale, Florida, United States

Site Status

Pill Box Pharmacy and Medical Supply

Pembroke Pines, Florida, United States

Site Status

Summerfield Pharmacy

Riverview, Florida, United States

Site Status

Sutton Family Pharmacy

Dalton, Georgia, United States

Site Status

Wynn's Pharmacy Inc.

Griffin, Georgia, United States

Site Status

Catonsville Pharmacy

Baltimore, Maryland, United States

Site Status

Kemper Drug

Elk River, Minnesota, United States

Site Status

Goodrich Pharmacy

Fridley, Minnesota, United States

Site Status

Northfield Pharmacy

Northfield, Minnesota, United States

Site Status

Cub Pharmacy

Rosemount, Minnesota, United States

Site Status

Goodrich Pharmacy

Saint Francis, Minnesota, United States

Site Status

Albers' Medical Pharmacy

Kansas City, Missouri, United States

Site Status

Countryside Pharmacy

Savannah, Missouri, United States

Site Status

Texas Road Pharmacy

Monroe, New Jersey, United States

Site Status

Duran Central Pharmacy

Albuquerque, New Mexico, United States

Site Status

Sam's Regent Pharmacy

Albuquerque, New Mexico, United States

Site Status

Family Prescription Center

Bethlehem, Pennsylvania, United States

Site Status

T.B. Bond Pharmacy

Hillsboro, Texas, United States

Site Status

Inwood Pharmacy

Houston, Texas, United States

Site Status

Brick Street Pharmacy

Tyler, Texas, United States

Site Status

Mountain West Apothecary

Bountiful, Utah, United States

Site Status

Ridgeview Pharmacy

Roy, Utah, United States

Site Status

The Apothecary Shoppe

Salt Lake City, Utah, United States

Site Status

The Medicine Center

Salt Lake City, Utah, United States

Site Status

Family Plaza Pharmacy

West Jordan, Utah, United States

Site Status

Montpelier Pharmacy, Inc.

Montpelier, Virginia, United States

Site Status

Lafayette Pharmacy

Richmond, Virginia, United States

Site Status

Jim's Pharmacy

Enumclaw, Washington, United States

Site Status

Ostrom Drugs

Kenmore, Washington, United States

Site Status

Katterman's Sand Point Professional Pharmacy

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A2581189

Identifier Type: -

Identifier Source: org_study_id

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