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Technology-Assisted Cholesterol Trial in Consumers (TACTiC) (TACTiC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04964544
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : November 25, 2021
Sponsor:
Collaborators:
Concentrics Research LLC
Concentrics Research - STATKING JV
Idea Evolver
The Cleveland Clinic
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
High Cholesterol Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 8, 2021
Estimated Primary Completion Date : February 20, 2023
Estimated Study Completion Date : February 20, 2023


Arm Intervention/treatment
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 Name: Crestor 5 mg




Primary Outcome Measures :
  1. Percentage of participants with an Overall Correct (correct + mitigated) Initial TASS Outcome at the initial self-selection [ Time Frame: -30 to -1 days from Day 0 Drug Delivery ]
    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

  2. Percentage of participants with an Overall Correct (correct + mitigated) Final Use Outcome at the final use assessment [ Time Frame: Through study completion, approximately 6 months ]
    Evaluate that participants are properly using non-prescription 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

  3. Percent change from baseline in verified LDL-C to Visit 2 [ Time Frame: Through study completion, approximately 6 months ]
    Effectiveness in lowering LDL-C


Secondary Outcome Measures :
  1. 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 [ Time Frame: Through study completion, approximately 6 months ]
    Compliance with cholesterol retesting within 6 months

  2. Percentage of participants who correctly self-identify as having a "Stop Use" warning and stop medication [ Time Frame: Through study completion, approximately 6 months ]
    Compliance with "Stop Use" warnings

  3. Percentage of participants who correctly self-identify as having a "Do Not Use" warning at the final use assessment [ Time Frame: Through study completion, approximately 6 months ]
    Compliance with "Do Not Use" warnings

  4. Percentage of participants who correctly self-identify as having an "Ask a Doctor Before Use" warning at the final use assessment [ Time Frame: Through study completion, approximately 6 months ]
    Compliance with "Ask a Doctor Before Use" warnings

  5. Percentage of participants with overall compliance between 50% and 120% as determined by pill count [ Time Frame: Through study completion, approximately 6 months ]
    Compliance with Continuous Dosing

  6. Percentage of participants with longitudinal compliance between 50% and 120% across all supply periods as determined using eDiary data [ Time Frame: Through study completion, approximately 6 months ]
    Compliance with Continuous Dosing

  7. Percentage of participants who were persistent as determined by reorder data from the Web App [ Time Frame: Through study completion, approximately 6 months ]
    Compliance with Continuous Dosing


Other Outcome Measures:
  1. List of the number and percentage of incorrect entries and the reasons for incorrect TASS entries for initial TASS [ Time Frame: -30 to -1 days from Day 0 Drug Delivery ]
    Evaluate the incorrect entries and the reasons for incorrect TASS entries for each question on the initial TASS assessment

  2. List of the number and percentage of incorrect entries and the reasons for incorrect TASS entries for final TASS [ Time Frame: Through study completion, approximately 6 months ]
    Evaluate the incorrect entries and the reasons for incorrect TASS entries for each question on the final TASS assessment

  3. Percentage of participants who correctly self-identify as having a "Stop Use" warning and speak to a doctor [ Time Frame: Through study completion, approximately 6 months ]
    Compliance with speak to a doctor component of the "Stop Use" warnings

  4. For participants who had 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 [ Time Frame: Through study completion, approximately 6 months ]
    Timeframe for complying with "Stop Use" warnings

  5. For participants who had 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 [ Time Frame: Through study completion, approximately 6 months ]
    Timeframe for complying with "Stop Use" warnings

  6. 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 [ Time Frame: Through study completion, approximately 6 months ]
    Timeframe for complying with "Do Not Use" warnings

  7. Percentage of participants who correctly self-identify as having an "Ask a Doctor Before Use" warning and speak to a doctor [ Time Frame: Through study completion, approximately 6 months ]
    Compliance with speak to a doctor component of the "Ask a Doctor Before Use" warnings

  8. 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 [ Time Frame: Through study completion, approximately 6 months ]
    Timeframe for complying with "Ask a Doctor Before Use" warnings

  9. 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 [ Time Frame: Through study completion, approximately 6 months ]
    Evaluate effectiveness in lowering LDL-C in different participant subgroups

  10. Percent change from baseline in verified LDL-C at Visit 2 stratified by level of overall compliance (<50%, 50-120% and >120%) and by supply period compliance (<50%, 50-120%, and >120%) in participants eligible for continuous treatment [ Time Frame: Through study completion, approximately 6 months ]
    Evaluate LDL-C lowering relative to level of dosing compliance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males, 20-75 years of age
  2. Females, 20-75 years of age (This inclusion will be applied until 50 females under the age of 50 years are enrolled in the study. After this quota of 50 females under the age of 50 years old are enrolled, the inclusion criteria will be revised to enroll only 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 and 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 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 SILS exclusion will be used to help increase the percentage of limited literacy participants at Virtual Visit 1. Participants identified as normal literacy by 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 breast-feeding.
  3. That the participant has an allergy to rosuvastatin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04964544


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, Indiana
Research Site Recruiting
Indianapolis, Indiana, United States, 46240
Sponsors and Collaborators
AstraZeneca
Concentrics Research LLC
Concentrics Research - STATKING JV
Idea Evolver
The Cleveland Clinic
Investigators
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Principal Investigator: William C. Miller, M.D. Concentrics Central Medical Operations Group
Additional Information:
Publications:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04964544    
Other Study ID Numbers: D356PL00015
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: November 25, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.

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.

URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Cholesterol, Web App
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors