Actual Use Trial of Atorvastatin Calcium 10 mg

Back to Search
Print
Bookmark Trial

NCT01964326

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Robert's Discount Pharmacy
Hoover, Alabama, 35226, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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

By email

Contact

[email protected]

Call Now

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
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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

HypercholesterolemiaStudy to Assess if Internet-Based Tailored Advice Could Modify Behaviour to Improve Health
NCT00220974
  1. Camperdown, New South Wales
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HypercholesterolemiaBioequivalence Study Of Pediatric Appropriate Formulation
NCT00758004
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HypercholesterolemiaBioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
NCT00917644
  1. Miami, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HypercholesterolemiaSingle Dose Study of PF-06815345 in Healthy Subjects
NCT02654899
  1. Brussels,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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 Allocation: N/A
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
 (submitted: April 18, 2016)		1311
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2013)		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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP