Actual Use Trial of Atorvastatin Calcium 10 mg

Study Overview
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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.

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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Atorvastatin calcium 10 mg


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin calcium 10 mg<br> | Drug: Atorvastatin calcium 10 mg<br>* Atorvastatin calcium 10 mg tablet to be administered orally every day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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. | Day 1 up to Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atorvastatin, Hypercholesterolemia