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ABOUT THIS STUDY
The purpose of this actual use study is to simulate the over the counter use of atorvastatin
calcium 10 mg.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- At least 18 years of age (19 in Alabama).
- Provide written informed consent.
- Never participated in a study about cholesterol medicines.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Females subjects who are pregnant or breastfeeding.
- Subjects with active liver disease.
- Subjects taking cyclosporine.
- Subjects with a known allergy to atorvastatin calcium.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Actual Use Trial of Atorvastatin Calcium 10 mg | |||
| Official Title ICMJE | A Multicenter, Actual Use Trial In A Simulated Over-the-counter Environment Of Atorvastatin Calcium 10 Mg | |||
| 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 Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Hypercholesterolemia | |||
| Intervention ICMJE | Drug: Atorvastatin calcium 10 mg
Atorvastatin calcium 10 mg tablet to be administered orally every day | |||
| Study Arms ICMJE | Experimental: Atorvastatin calcium 10 mg
Intervention: Drug: Atorvastatin calcium 10 mg | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 1311 | |||
| Original Estimated Enrollment ICMJE | 1200 | |||
| Actual Study Completion Date ICMJE | December 2014 | |||
| Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01964326 | |||
| Other Study ID Numbers ICMJE | A2581189 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||