Technology-Assisted Cholesterol Trial in Consumers (TACTiC)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-08

Study Completion Date

2023-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Crestor® (Rosuvastatin) in Daily Practice

NCT00837083

Hypercholesterolemia

COMPLETED

A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Hypercholesterolemia.

NCT01982461

Hypercholesterolemia

UNKNOWN NA

STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

NCT00654537

Hypercholesterolemia

COMPLETED PHASE3

Supplements, Placebo, or Rosuvastatin Study

NCT04846231

Hypercholesterolemia

COMPLETED PHASE2

Compare the Safety & Efficacy of Rosuvastatin 40mg in Combination With Ezetimibe 10mg

NCT00653445

Hypercholesterolemia Coronary Heart Disease Atherosclerosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

High Cholesterol

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Crestor 5 mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No