Phase 3
Completed N=1,311
Actual Use Trial of Atorvastatin Calcium 10 mg
Source: ClinicalTrials.gov NCT01964326 ↗Enrolled (actual)
1,311
Serious AEs
4.3%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level — 49.7 Percentage of participants
Summary
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level |
49.7 | — |
| PRIMARY Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results |
52.6 | — |
| SECONDARY 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 |
29.2 | — |
| SECONDARY 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 |
10.2 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01964326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.