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Completed

NCT Number: NCT01964326

Actual Use Trial of Atorvastatin Calcium 10 mg

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Robert's Discount Pharmacy, Hoover, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atorvastatin calcium 10 mg

Drug

Atorvastatin calcium 10 mg tablet to be administered orally every day

Primary outcomes

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

    Time frame: Day 1 up to Week 26

    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.

  2. Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results

    Time frame: Day 1 up to Week 26

    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 outcomes

  1. 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

    Time frame: Day 1 up to Week 26

    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.

  2. 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

    Time frame: Day 1 up to Week 26

    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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 17, 2013
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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