Technology-Assisted Cholesterol Trial in Consumers (TACTiC) (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

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.

Study Overview

• Status: Completed
• Conditions: High Cholesterol
• Intervention / Treatment: Combination product: 5 mg rosuvastatin calcium with a Web App (combination product)

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.

• Study Type: Interventional
• Enrollment (Actual): 1189
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Open Label, Single Arm Technology-Assisted Cholesterol Trial; 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); 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.; Other Names: Crestor 5 mg

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
List of the number and percentage of incorrect entries and the reasons for incorrect TASS entries for initial TASS	Evaluate the incorrect entries and the reasons for incorrect TASS entries for each question on the initial TASS assessment	-30 to -1 days from Day 0 Drug Delivery
List of the number and percentage of incorrect entries and the reasons for incorrect TASS entries for final TASS	Evaluate the incorrect entries and the reasons for incorrect TASS entries for each question on the final TASS assessment	Through study completion, approximately 6 months
Percentage of participants who correctly self-identify as having a "Stop Use" warning and speak to a doctor	Compliance with speak to a doctor component of the "Stop Use" warnings	Through study completion, approximately 6 months
For participants who correctly self-identify as having a "Do Not Use" warning at final use assessment, the date from when a participant self-identifies a "Do Not Use" warning to the date the medication was stopped	Timeframe for complying 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 and speak to a doctor	Compliance with speak to a doctor component of the "Ask a Doctor Before Use" warnings	Through study completion, approximately 6 months
For participants who correctly self-identify as having an "Ask a Doctor Before Use" warning at final use assessment, the date from participant receiving an "Ask a Doctor Before Use" warning to the date their doctor was contacted	Timeframe for complying with "Ask a Doctor Before Use" warnings	Through study completion, approximately 6 months
Difference in % change from baseline in LDL-C between participants who had a retest during the study with a verified source and those who did not retest but had a study mandated test completed based on participants eligible for continuous treatment at V2	Evaluate effectiveness in lowering LDL-C in different participant subgroups	Through study completion, approximately 6 months
Percent change from baseline in verified LDL-C at Visit 2 stratified by level of overall compliance (<50%, 50-120% and >120%) and by 50-120% supply period compliance across all supply periods in participants eligible for continuous treatment	Evaluate LDL-C lowering relative to level of dosing compliance	Through study completion, approximately 6 months
For participants who correctly self-identify a "Stop Use" warning and stopped the medication, the date from when participant self-identifies a "Stop Use" warning to the date the medication was stopped	Timeframe for complying with "Stop Use" warnings	Through study completion, approximately 6 months
For participants who correctly self-identify a "Stop Use" warning and talked to a doctor, the date from when a participant self-identifies a "Stop Use" warning to the date their doctor was contacted	Timeframe for complying with "Stop Use" warnings	Through study completion, approximately 6 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: The Cleveland Clinic; Concentrics Research LLC; Concentrics Research - STATKING JV; Idea Evolver
• Investigators: Principal Investigator: William C. Miller, M.D., Concentrics Central Medical Operations Group

Publications and helpful links

General Publications

• Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, Vanryn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008 May;23(5):561-6. doi: 10.1007/s11606-008-0520-5. Epub 2008 Mar 12.
• Davis TC, Long SW, Jackson RH, Mayeaux EJ, George RB, Murphy PW, Crouch MA. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med. 1993 Jun;25(6):391-5.
• Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10. Erratum In: Circulation. 2019 Jun 18;139(25):e1182-e1186. Circulation. 2023 Aug 15;148(7):e5.

Helpful Links

• Study Landing Page

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cholesterol, Web App
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Calcium-Regulating Hormones and Agents; Rosuvastatin Calcium; Calcium
• Other Study ID Numbers: D356PL00015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No