Technology-Assisted Cholesterol Trial in Consumers (TACTiC)

High Cholesterol Clinical Trial

— TACTiC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964544
• Other study ID #: D356PL00015
• Status: Completed
• Phase: Phase 3
• Start date: July 8, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1196
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Cholesterol
• Hypercholesterolemia

Intervention

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.

Locations

Country	Name	City	State
United States	Research Site	Indianapolis	Indiana

Sponsors (5)

Lead Sponsor	Collaborator
AstraZeneca	Concentrics Research - STATKING JV, Concentrics Research LLC, Idea Evolver, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Study Landing Page