Actual Use Trial of Atorvastatin Calcium 10 mg
- Registration Number
- NCT01964326
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1311
- At least 18 years of age (19 in Alabama).
- Provide written informed consent.
- Never participated in a study about cholesterol medicines.
- Females subjects who are pregnant or breastfeeding.
- Subjects with active liver disease.
- Subjects taking cyclosporine.
- Subjects with a known allergy to atorvastatin calcium.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Atorvastatin calcium 10 mg Atorvastatin calcium 10 mg -
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level 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.
Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results 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 Outcome Measures
Name Time Method 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 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.
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 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.
Trial Locations
- Locations (36)
Robert's Discount Pharmacy
🇺🇸Hoover, Alabama, United States
Pharmacy at the Pig
🇺🇸McCalla, Alabama, United States
Pinson Discount Drugs
🇺🇸Pinson, Alabama, United States
Community Clinical Pharmacy
🇺🇸Mesa, Arizona, United States
Melrose Pharmacy
🇺🇸Phoenix, Arizona, United States
Bi-Rite Quality Pharmacies
🇺🇸La Habra, California, United States
Parkview Compounding Pharmacy
🇺🇸Rancho Cucamonga, California, United States
Garden Drug
🇺🇸Fort Lauderdale, Florida, United States
Pill Box Pharmacy and Medical Supply
🇺🇸Pembroke Pines, Florida, United States
Summerfield Pharmacy
🇺🇸Riverview, Florida, United States
Scroll for more (26 remaining)Robert's Discount Pharmacy🇺🇸Hoover, Alabama, United States