Actual Use Trial of Atorvastatin Calcium 10 mg
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| ClinicalTrials.gov Identifier: NCT01964326 |
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Recruitment Status :
Completed
First Posted : October 17, 2013
Results First Posted : January 27, 2016
Last Update Posted : May 18, 2016
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief Summary:
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: Atorvastatin calcium 10 mg | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1311 participants |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Actual Use Trial In A Simulated Over-the-counter Environment Of Atorvastatin Calcium 10 Mg |
| Study Start Date : | October 2013 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Atorvastatin calcium 10 mg |
Drug: Atorvastatin calcium 10 mg
Atorvastatin calcium 10 mg tablet to be administered orally every day |
Primary Outcome Measures :
- 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.
- 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 Outcome Measures :
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964326
Locations
Show 37 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01964326 |
| Other Study ID Numbers: |
A2581189 |
| First Posted: | October 17, 2013 Key Record Dates |
| Results First Posted: | January 27, 2016 |
| Last Update Posted: | May 18, 2016 |
| Last Verified: | April 2016 |
Keywords provided by Pfizer:
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atorvastatin Hypercholesterolemia |
Additional relevant MeSH terms:
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Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Calcium Calcium-Regulating Hormones and Agents |
Physiological Effects of Drugs Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |