Technology-Assisted Cholesterol Trial in Consumers (TACTiC)

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04964544

Acronym

TACTiC

Enrollment

1196

Registered

2021-07-16

Start date

2021-07-08

Completion date

2023-03-01

Last updated

2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Cholesterol

Keywords

Cholesterol, Web App

Brief 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.

Detailed 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.

Interventions

COMBINATION_PRODUCT5 mg rosuvastatin calcium with a Web App (combination product)

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Males, 20-75 years of age 2. 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). 3. Respond to advertising regarding a concern about high cholesterol or heart health 4. 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

1. 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 2. The participant has ever been trained or employed as a healthcare professional (physician, nurse, nurse practitioner, physician assistant, pharmacist). 3. 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 4. The participant is not willing to provide contact information. 5. Previous enrollment in the present study. 6. The participant has a mailing address in Alaska or their mailing address is a Post Office (PO) Box. 7. The participant is not willing to complete an eDiary 8. 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. 9. The participant does not have access to the internet. 10. The participant does not have an email address or the ability to receive emails. 11. 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.) 12. 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: 1. 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). 2. That the participant is breastfeeding. 3. That the participant has an allergy to rosuvastatin.

Design outcomes

Primary

Measure	Time frame	Description
Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population)	Study day -30 to -1, at initial TASS assessment	Proportion of participants that had a correct tass outcome at their initial TASS assessment
Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population)	From enrollment to end of the home use period at 180 days, at final TASS Assessment	Proportion of participants that had a correct tass outcome at their final TASS assessment
Percent Change From Baseline in Verified LDL-C Regardless of Final Use Outcome (AUS ITT Population)	From enrollment to end of the home use period at 180 days, at final assessment	—

Secondary

Measure	Time frame	Description
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)	From enrollment to end of the home use period at 180 days	—
Participants With Overall Compliance Between 50% and 120%	From enrollment to end of the home use period at 180 days	Overall compliance is defined as 100 \* (total number of pills taken) / (Intended duration of treatment in days)
Participants Eligble for Continuous Treatment Who Self-Tested With a Verified LDL-C Retest During Study, Overall and by Subgroups (Per Protocol Population)	From enrollment to end of the home use period at 180 days	—
Participants Who Were Persistent (Per Protocol Population)	From enrollment to end of the home use period at 180 days	An individual is persistent if they ordered the full 180 days of treatment and were eligible for continuous treatment
Participants Who Were Longitudinally Compliant (Per Protocol Population)	From enrollment to end of the home use period at 180 days	An individual is longitudinally compliant if they have 50% to 120% compliance across each supply period.
Participants Who Self-Identify a Stop Use Warning Also Identified by the CMOG, and Stop Medication (Per Protocol Population)	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.
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)	From enrollment to end of the home use period at 180 days	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Nonprescription Rosuvastatin Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)	1,196
Total	1,196

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	1
Overall Study	Lost to Follow-up	9
Overall Study	Physician Decision	4
Overall Study	Screen failure or other uncategorised	10
Overall Study	Withdrawal by Subject	18

Baseline characteristics

Characteristic	Nonprescription Rosuvastatin
Age, Continuous	61.6 Years STANDARD_DEVIATION 8.1
Age, Customized 20-29 years of age	4 Participants
Age, Customized 30-39 years of age	18 Participants
Age, Customized 40-49 years of age	64 Participants
Age, Customized 50-59 years of age	334 Participants
Age, Customized 60-69 years of age	598 Participants
Age, Customized 70-75 years of age	178 Participants
Age, Customized 76+ years of age	0 Participants
Age, Customized Under 20 years of age	0 Participants
Race/Ethnicity, Customized Asian (China, Philippines, Vietnam, Korea, etc.)	34 Participants
Race/Ethnicity, Customized Black or African American	140 Participants
Race/Ethnicity, Customized Hispanic	38 Participants
Race/Ethnicity, Customized Other	21 Participants
Race/Ethnicity, Customized South Asian (India, Pakistan, Bangladesh, etc.)	14 Participants
Race/Ethnicity, Customized White	949 Participants
Sex: Female, Male Female	474 Participants
Sex: Female, Male Male	722 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 1,177
other Total, other adverse events	493 / 1,177
serious Total, serious adverse events	27 / 1,177

Outcome results

Primary

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nonprescription Rosuvastatin	Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population)	1132 Participants

Comparison: Proportion of participants with overall correct final TASS assessment, with mitigations, worst case imputation (Per Protocol Population)95% CI: [97.1, 98.8]

Primary

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Nonprescription Rosuvastatin	Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population)	1085 Participants

Comparison: Proportion of participants with overall correct initial TASS assessment, with mitigations, worst case imputation (Self-Selection Population)95% CI: [88.9, 92.3]

Primary

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

Arm	Measure	Value (MEAN)
Nonprescription Rosuvastatin	Percent Change From Baseline in Verified LDL-C Regardless of Final Use Outcome (AUS ITT Population)	-35.48 Percent change of baseline

95% CI: [-36.63, -34.33]

Secondary