ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
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Descriptive Information | ||||
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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:
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Sex/Gender ICMJE |
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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 |
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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 |