Technology-Assisted Cholesterol Trial in Consumers (TACTiC)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase III, 6-Month Self-selection and Actual Use Study for Rx-to-OTC Switch of Rosuvastatin 5 mg Once-daily in Combination With a Web App

Conditions
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High Cholesterol

Intervention / Treatment
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* Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males, 20-75 years of age Females, 20-75 years of age (This inclusion criterion will be applied until 50 females under the age of 50 years complete the initial TASS assessment in the Web App). After this quota of 50 females under the age of 50 years old is met, the inclusion criterion will be revised to 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) 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 or 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 2 (SILS2) 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 SILS2 exclusion will be used to help increase the percentage of limited literacy participants at Virtual Visit 1. Participants identified as normal literacy by Rapid Estimate of Adult Literacy in Medicine [REALM] testing at Virtual Visit 1 will not be excluded from entry into the treatment phase of the study.) 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. 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 breastfeeding. That the participant has an allergy to rosuvastatin.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a 6-month, single-arm, uncontrolled technology-assisted Self-Selection and Actual Use Study to evaluate the use of nonprescription rosuvastatin 5 mg in combination with a Web App. It is an open-label study where participants qualify for treatment based on the medical history, laboratory and blood pressure data they enter into the Web App, accessed on their own device on the internet.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open Label, Single Arm Technology-Assisted Cholesterol Trial<br>Open Label Single Arm study in All-comers population who self-report having concern about high cholesterol or heart health | Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)<br>* The combination product will be a Drug (Rosuvastatin calcium 5 mg) and Software as a Medical Device (Web App that features a Technology-Assisted Self-Selection (TASS) tool). Rosuvastatin calcium 5 mg will be taken orally, 1 tablet daily to use for lowering cholesterol, a key risk factor that can lead to heart disease.<br>* Other names: Crestor 5 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with an Overall Correct (correct + mitigated) Initial TASS Outcome at the initial self-selection | Evaluate initial TASS outcome (for participants deemed OK to Use or those with an Ask a Doctor outcome who contact a doctor and are permitted to continue treatment) compared to the TASS outcome obtained using clinician-verified medical and laboratory data | -30 to -1 days from Day 0 Drug Delivery | 
| Percentage of participants with an Overall Correct (correct + mitigated) Final Use Outcome at the final use assessment | Evaluate that participants are properly using nonprescription rosuvastatin during the use period as assessed by their ability to correctly enter their ongoing health status into the Web App to get the correct outcome or through the medical and medication history in those participants who fail to complete a final TASS use assessment | Through study completion, approximately 6 months | 
| Percent change from baseline in verified LDL-C to Visit 2 | Effectiveness in lowering LDL-C in participants regardless of final use outcome | Through study completion, approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol retest within 6 months of starting medication (that was verified at Visit 2, not including study mandated tests) by at least 60% of participants who are eligible for continuous treatment | Compliance with cholesterol retesting within 6 months | Through study completion, approximately 6 months | 
| Percentage of participants who correctly self-identify as having a Stop Use warning and stop medication | Compliance with Stop Use warnings | Through study completion, approximately 6 months | 
| Percentage of participants who correctly self-identify as having a Do Not Use warning at the final use assessment | Compliance with Do Not Use warnings | Through study completion, approximately 6 months | 
| Percentage of participants who correctly self-identify as having an Ask a Doctor Before Use warning at the final use assessment | Compliance with Ask a Doctor Before Use warnings | Through study completion, approximately 6 months | 
| Percentage of participants with overall compliance between 50% and 120% as determined by pill count | Compliance with Continuous Dosing | Through study completion, approximately 6 months | 
| Percentage of participants with longitudinal compliance between 50% and 120% across all supply periods as determined using eDiary data | Compliance with Continuous Dosing | Through study completion, approximately 6 months | 
| Percentage of participants who were persistent as determined by reorder data from the Web App | Compliance with Continuous Dosing | Through study completion, approximately 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, Web App