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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,196
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.
Research Site
Indianapolis, Indiana, United States
Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population)
Proportion of participants that had a correct tass outcome at their initial TASS assessment
Time frame: Study day -30 to -1, at initial TASS assessment
Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population)
Proportion of participants that had a correct tass outcome at their final TASS assessment
Time frame: From enrollment to end of the home use period at 180 days, at final TASS Assessment
Percent Change From Baseline in Verified LDL-C Regardless of Final Use Outcome (AUS ITT Population)
Time frame: From enrollment to end of the home use period at 180 days, at final assessment
Participants Eligble for Continuous Treatment Who Self-Tested With a Verified LDL-C Retest During Study, Overall and by Subgroups (Per Protocol Population)
Time frame: From enrollment to end of the home use period at 180 days
Participants Who Self-Identify a Stop Use Warning Also Identified by the CMOG, and Stop Medication (Per Protocol Population)
Participants who Self-Identify a Stop Use Warning also identified by the CMOG, and Stop Medication.
Time frame: From enrollment to end of the home use period at 180 days
Participants Who Self-Identify a Do Not Use Warning Also Identified by the CMOG at Final Use Assessment(Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit)
Time frame: From enrollment to end of the home use period at 180 days
Participants Who Self-Identify an Ask a Doctor Before Use Warning Also Identified by the CMOG at Final Use Assessment (Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit)
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Time frame: From enrollment to end of the home use period at 180 days
Participants With Overall Compliance Between 50% and 120%
Overall compliance is defined as 100 \* (total number of pills taken) / (Intended duration of treatment in days)
Time frame: From enrollment to end of the home use period at 180 days
Participants Who Were Longitudinally Compliant (Per Protocol Population)
An individual is longitudinally compliant if they have 50% to 120% compliance across each supply period.
Time frame: From enrollment to end of the home use period at 180 days
Participants Who Were Persistent (Per Protocol Population)
An individual is persistent if they ordered the full 180 days of treatment and were eligible for continuous treatment
Time frame: From enrollment to end of the home use period at 180 days