Technology-Assisted Cholesterol Trial in Consumers (TACTiC)

  • STATUS
    Recruiting
  • End date
    Apr 5, 2022
  • participants needed
    1220
  • sponsor
    AstraZeneca
Updated on 19 September 2021

Summary

The purpose of this AUS is to evaluate the extent to which participants can safely and effectively self-select, purchase, and use Crestor OTC 5 mg for a 6-month period according to the label.

Description

This is a single-arm, interventional, phase III Self-Selection (SS) and Actual Use Study (AUS) using a technology assisted tool within a Web App. The open-label study will enroll approximately 1220 participants who qualify for treatment based on the data they enter into the Web App of which an estimated 1000 participants will ultimately proceed to the use phase.

Details
Condition Hypercholesterolemia, High Cholesterol, elevated cholesterol, hypercholesteremia
Treatment 5 mg rosuvastatin calcium with a Web App (combination product)
Clinical Study IdentifierNCT04964544
SponsorAstraZeneca
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males, 20-75 years of age
Females, 20-75 years of age (This inclusion will be applied until 50 females under the age of 50 years are enrolled in the study. After this quota of 50 females under the age of 50 years old are enrolled, the inclusion criteria will be revised to enroll only females 50-75 years old)
Respond to advertising regarding a concern about high cholesterol or heart health
Able to read speak and understand English
Additional Criteria for Inclusion for Actual Use (at Virtual Visit 1)
Participant reads and signs the Informed Consent form

Exclusion Criteria

The participant or anyone in their household is currently employed by any of the
following
A pharmacy or pharmaceutical company
A consumer healthcare company
A manufacturer of medicines
A managed care or health insurance company
A healthcare practice
An employee of AstraZeneca and Concentrics Research
The participant has ever been trained or employed as a healthcare professional (physician, nurse, nurse practitioner, physician assistant, pharmacist)
The participant has, or cannot recall whether he/she has, received an investigational therapy as part of a clinical trial in the previous twelve (12) months
The participant is not willing to provide contact information
Previous enrollment in the present study
The participant has a mailing address in Alaska or their mailing address is a Post Office (PO) Box
The participant is not willing to complete an eDiary
The participant is a woman of childbearing potential and is not following contraception guidelines or is not willing to follow contraception guidelines including practicing abstinence or using at least 1 of the following acceptable methods of birth control for at least 1 month prior to entry into the study and for 1 month after study completion: hormonal -oral, implantable, injectable, or transdermal; mechanical - spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device; or surgical sterilization of partner
The participant does not have access to the internet
The participant does not have an email address or the ability to receive emails
The participant responds to the Single Item Literacy Screener question (See References) with either 'extremely' or 'quite a bit.' (If the quota for normal literacy is met, but the limited literacy target is not met, the SILS exclusion will be used to help increase the percentage of limited literacy participants at Virtual Visit 1. Participants identified as normal literacy by REALM testing at Virtual Visit 1 will not be excluded from entry into the treatment phase of the study.)
Additional Criteria for Exclusion from Actual Use (at Virtual Visit 1)
Confirmation by Concentrics Central Medical Operations Group (CMOG) clinician
That the participant is pregnant, as determined by an approved self-administered OTC urine pregnancy test (UPT) conducted for all female participants of childbearing potential (Female participants who are not post-menopausal or surgically sterile)
That the participant is breast-feeding
That the participant has an allergy to rosuvastatin
Inability to conduct interviews in a private location so that sensitive information about the participant or study would not be overheard by others not permitted to hear such information
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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