High CholesterolPhase 3TACTiCNCT04964544
Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
A Phase 3 study testing 5 mg rosuvastatin calcium with a Web App (combination product) in people with High Cholesterol, run by AstraZeneca at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- High Cholesterol
- What is being tested?
- 5 mg rosuvastatin calcium with a Web App (combination product)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,196 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2021to 1 Mar 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males, 20-75 years of age
- 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).
- Respond to advertising regarding a concern about high cholesterol or heart health
- 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
Who cannot join
- 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
Show all 23Show fewer
- An employee of AstraZeneca or Concentrics Research
- The participant has ever been trained or employed as a healthcare professional (physician, nurse, nurse practitioner, physician assistant, pharmacist).
- 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
- The participant is not willing to provide contact information.
- Previous enrollment in the present study.
- The participant has a mailing address in Alaska or their mailing address is a Post Office (PO) Box.
- The participant is not willing to complete an eDiary
- 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.
- The participant does not have access to the internet.
- The participant does not have an email address or the ability to receive emails.
- 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.)
- 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:
- 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).
- That the participant is breastfeeding.
- That the participant has an allergy to rosuvastatin.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- High Cholesterol
- Being tested
- 5 mg rosuvastatin calcium with a Web App (combination product)
- Keywords
- Cholesterol, Web App
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 mg rosuvastatin calcium with a Web App (combination product)Combination product
Also called Crestor 5 mg
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 group | Role | What they receive |
|---|---|---|
| Open Label, Single Arm Technology-Assisted Cholesterol Trial | Other | Open Label Single Arm study in All-comers population who self-report having concern about high cholesterol or heart health Receives: Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: From enrollment to end of the home use period at 180 days, at final assessment
Secondary outcomes (7)
Participants Eligble for Continuous Treatment Who Self-Tested With a Verified LDL-C Retest During Study, Overall and by Subgroups (Per Protocol Population)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: From enrollment to end of the home use period at 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start8 Jul 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High CholesterolStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 1,196 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Concentrics Research, Idea Evolver, The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- William C. Miller, M.D., Principal investigator, Concentrics Central Medical Operations Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964544
- Sponsor's protocol ID
- D356PL00015
- Acronym
- TACTiC
- Status last verified
- Oct 2024
- First submitted
- 22 Jun 2021
- Last updated
- 30 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 18335281Davis 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.
PubMed 8349060Grundy 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.
PubMed 30586774Nissen SE, Hutchinson HG, Wolski K, Watson K, Martin SS, Michos ED, Weintraub WS, Morris M, Cho L, Laffin L, Jacoby D, Ballantyne CM, Ekelund J, Birve F, Menon V, Strzelecki M, Ridker PM. A Technology-Assisted Web Application for Consumer Access to a Nonprescription Statin Medication. J Am Coll Cardiol. 2024 May 28;83(21):2080-2088. doi: 10.1016/j.jacc.2024.03.388. Epub 2024 Apr 8.
PubMed 38599257
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04964544
- Acronym / sponsor ID
- TACTiC / D356PL00015
- Conditions
- High Cholesterol
- Keywords
- Cholesterol, Web App
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,196 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Concentrics Research, Idea Evolver, The Cleveland Clinic
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 30 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open Label, Single Arm Technology-Assisted Cholesterol Trial | Other | Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product)Open Label Single Arm study in All-comers population who self-report having concern about high cholesterol or heart health |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males, 20-75 years of age
- 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).
- Respond to advertising regarding a concern about high cholesterol or heart health
- Able to read speak and understand English
- Additional Criteria for Inclusion for Actual Use (at Virtual Visit 1)
Key exclusion criteria (23 listed)
- The participant or anyone in their household is currently employed by any of the following:
- The participant has ever been trained or employed as a healthcare professional (physician, nurse, nurse practitioner, physician assistant, pharmacist).
- 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
- The participant is not willing to provide contact information.
- Previous enrollment in the present study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 mg rosuvastatin calcium with a Web App (combination product)Also: Crestor 5 mgThe 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. | Combination product | Open Label, Single Arm Technology-Assisted Cholesterol Trial |
Primary outcome
Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population)
Time frame: 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)
Time frame: 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)
Time frame: From enrollment to end of the home use period at 180 days, at final assessment
7 secondary outcomes
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)
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)
Time frame: From enrollment to end of the home use period at 180 days
Participants With Overall Compliance Between 50% and 120%
Time frame: From enrollment to end of the home use period at 180 days
Participants Who Were Longitudinally Compliant (Per Protocol Population)
Time frame: From enrollment to end of the home use period at 180 days
Participants Who Were Persistent (Per Protocol Population)
Time frame: From enrollment to end of the home use period at 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18335281Chew 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.
- Background: PubMed 8349060Davis 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.
- Background: PubMed 30586774Grundy 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.
- Derived from this study: PubMed 38599257Nissen SE, Hutchinson HG, Wolski K, Watson K, Martin SS, Michos ED, Weintraub WS, Morris M, Cho L, Laffin L, Jacoby D, Ballantyne CM, Ekelund J, Birve F, Menon V, Strzelecki M, Ridker PM. A Technology-Assisted Web Application for Consumer Access to a Nonprescription Statin Medication. J Am Coll Cardiol. 2024 May 28;83(21):2080-2088. doi: 10.1016/j.jacc.2024.03.388. Epub 2024 Apr 8.
- redacted CSPLink provided by the sponsor.
- redacted SAPLink provided by the sponsor.
- redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William C. Miller, M.D. principal investigator
Concentrics Central Medical Operations Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5 mg rosuvastatin calcium with a Web App (combination product) in people with High Cholesterol, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population) (time frame: Study day -30 to -1, at initial TASS assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04964544, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.